titanium cannulated adolescent lateral entry femoral nailsynthes.vo.llnwd.net/o16/llnwmb8/us...

Titanium Cannulated AdolescentLateral Entry Femoral Nail. ExpertNailing System.

Technique Guide

EXPERT NailingSystem

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Introduction

Surgical Technique

Product Information

Table of Contents

Titanium Cannulated Adolescent Lateral Entry 2Femoral Nail Expert System

AO Principles 4

Indications 5

Clinical Cases 6

Preoperative Planning 10

Opening the Femur 13

Inserting the Nail 21

Locking Options 26

Proximal Locking 28

Distal Locking 37

End Cap Insertion 42

Implant Removal (Optional) 44

Implants 46

Instruments 52

Set Lists 58

Image intensifier control

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Titanium Cannulated Adolescent Lateral Entry Femoral Nail Expert System

Improved instrumentation– Easy-to-use instrumentation facilitates

the surgical procedure

– Ball-tip reaming rod can be removedthrough the nail and insertion instruments, eliminating the need for an exchange tube

2 Synthes Titanium Cannulated Adolescent Lateral Entry Femoral Nail Technique Guide

1. L. Ehmke, B. Polzin, C. Roth, M. Bottlang, “Femoral Nailing Through theTrochanter: The Reamer Pathway indicates A Helical Shape,” Journal ofOrthopedic Trauma, Vol. 20, Number 10, November/December 2006, p. 668-674.

End caps– Prevent ingrowth of tissue and

facilitate nail extraction

– Self-retaining, T40 StarDrive recessfor easy pickup and insertion of theend cap

– Cannulated for insertion over a guide wire

– 0 mm end cap sits flush with the nail

– 5 mm, 10 mm, and 15 mm end caps extend nail height if the nail is overinserted

Nail features– Design accommodates a lateral entry

site through the greater trochanter

– Anatomic nail design based on a femoral canal study1

– Cannulated nail for reamed or unreamed techniques

– Lengths from 240 mm to 400 mm, in 20 mm increments

– Designed for use in patients where Titanium Elastic Nails are not largeenough and the Lateral Entry Femoral Nail–EX is too large

– 8.2 mm, 9 mm, and 10 mm diameter nail with 11 mm diameterproximal ends


Standard locking screws– Double-lead thread for ease of insertion

– Thread closer to screwhead provides better bone purchasein the near cortex and improved stability

– Titanium alloy* for improved mechanical and fatigue properties

– Self-tapping blunt tip

– Self-retaining T25 StarDrive recess allows improved torquetransmission, increased resistance to stripping relative to a hex recess, and secure locking screw pickup

– 4.0 mm diameter

5.0 mm recon screws– Lengths from 50 mm to 125 mm in 5 mm increments

– Self-retaining T25 StarDrive recess

– Titanium alloy*

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* Titanium-6% aluminum-7% niobium alloy


AO Principles

In 1958, the AO formulated four basic principles, which havebecome the guidelines for internal fixation in general, and intramedullary nailing in particular :2

Anatomic reductionThe Titanium Cannulated Adolescent Lateral Entry ExpertFemoral Nail is designed to fit anatomically in the medullarycanal and allows indirect reduction.

Stable fixationThe intramedullary nail acts as an internal splint that controlsbut does not prevent micromovements of the fragments. Itprovides relative stability that leads to an indirect healingthrough callus formation.

Preservation of blood supplyThe instruments and implants in the Adolescent Lateral Entry Femoral Nail Expert System permit a minimally invasive technique and less tissue stripping than other treatmentmethods. An intramedullary approach results in decreasedblood loss compared to plate fixation.

Early, active mobilizationThe Titanium Cannulated Adolescent Lateral Entry ExpertFemoral Nail provides secure fixation which permits controlled, early, active rehabilitation conducive to optimal recovery.


2. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger, Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag, 1991.


Indications

The Adolescent Lateral Entry Femoral Nail–EX is indicated foruse in adolescent and small-stature adult patients to stabilize:

– Fractures of the femoral shaft

– Subtrochanteric fractures

– Ipsilateral neck/shaft fractures

– Impending pathologic fractures

– Nonunions and malunions

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Clinical Cases

Case 1–standard transverse locking

– 16-year-old female, 45 kg

– Isolated transverse femoral shaft fracture

Case 2–antegrade locking

– 15-year-old male, 55 kg

– Oblique midshaft femoral shaft fracture

Preoperative

Preoperative


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Postoperative Follow-up (6 weeks after surgery)

Postoperative Follow-up (4 months after surgery)



Clinical Cases continued

Case 3–recon locking


– Pathologic proximal femoral shaft fracture

Case 4 – distal locking


– Oblique distal third femoral shaft fracture

Preoperative

Preoperative


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Postoperative Follow-up (3 weeks after surgery)

Postoperative Follow-up (1 month after surgery)


Preoperative Planning

Use the AO preoperative planner templates for the Adoles-cent Lateral Entry Femoral Nail–EX to estimate nail lengthand diameter.

To estimate nail diameter, place the template on the AP orlateral x-ray of the femur and measure the diameter of themedullary canal at the narrowest part that will contain the nail.

To estimate nail length, place the template on the AP x-ray of the uninjured femur and select the appropriate nail lengthbased on patient anatomy. When selecting nail size, considercanal diameter, fracture pattern, patient anatomy and postoperative protocol.

Note: Templates are available in two sizes: actual size and115% magnification in which the image is enlarged 15% tocorrespond to typical radiographic magnification; however,variations in magnification levels are common.

1Position patient

Position the patient in the lateral decubitus or supine positionon a fracture table or radiolucent operating table. Positionthe C-arm to allow visualization of the proximal femur inboth the AP and lateral planes.

To facilitate access to the medullary canal, abduct the upperpart of the body approximately 10°–15° to the contralateralside and adduct the affected limb by 10°–15°.


Affected leg10º–15º adduction

AO


2Reduce fracture

Instrument

394.35 Large Distractor*

Perform closed reduction manually by axial traction underimage intensifier control. The use of the large distractor maybe appropriate in certain circumstances.

3Confirm nail length

Instrument

03.010.020 Radiographic Ruler for Titanium CannulatedFemoral Nails

The required nail length must be determined after reductionof the femoral fracture.

Position the C-arm for an AP view of the proximal femur.With long forceps, hold the ruler alongside the lateral thigh,parallel to and at the same level as the femur. Adjust theruler until the proximal end is at the desired nail insertiondepth. Mark the skin at the proximal end of the ruler.

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* Also available


Preoperative Planning continued

3Confirm nail length continued

Move the C-arm to the distal femur. Verify fracture reduction.Align the proximal end of the radiographic ruler to the skinmark, and take an AP image of the distal femur.

Read nail length directly from the ruler image, selecting themeasurement proximal to the epiphysis, or at the chosen insertion depth.

Notes:It is recommended to treat the fracture with the longest nailpossible without crossing the physis, taking into account patient anatomy or a previous implant. The distal end of thenail should be 15 mm from the physis.

Back-hammering or dynamization to close a fracture gap must be taken into account when determining the nail length.A shorter nail should be chosen when back-hammering or dynamization is planned. The dynamic slot allows 7 mm of movement.

4Confirm canal diameter

Instrument

03.010.023 Radiographic Canal Width Estimator

Position the C-arm for an AP or lateral view of the femur at the level of the isthmus. Hold the radiographic canal width estimator over the femur with the diameter gauge centered over the narrowest part of the medullary canal.Read the estimated diameter measurement on the circularindicator that fills the canal.

Note: If the reamed technique is used, the diameter of thelargest medullary reamer must be at least 1.0 mm greaterthan the nail diameter.



Opening the Femur

1Approach

Palpate the posterior edge of the greater trochanter.

Make a 3 cm incision in line with the central axis of the intramedullary canal in the lateral view, and depending on the anatomy of the patient, 2–5 cm proximal to the tip of the greater trochanter.

2Determine entry point

The insertion point is 12° lateral to the greater trochanter, asmeasured from a point 20 mm distal to the lesser trochanter.

The entry point can also be described as lateral to the greatertrochanter at the same level as the superior aspect of thebase of the femoral neck (just above the piriformis fossa).This point can be found by extending a line horizontally fromthe base of the femoral neck to the lateral side of the femur.

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20 mm

12°


Opening the Femur continued

3Insert guide wire

Instruments

03.010.031 13.0 mm/3.2 mm Wire Guide with trocar tip

03.010.229 13.0 mm Protection Sleeve, short

357.393 3.2 mm Trocar

357.399 3.2 mm Guide Wire

Insert the protection sleeve, wire guide and trocar assemblyinto the incision site and to the bone.

Remove the trocar. Insert the guide wire through the wire guide.

The guide wire must be inserted laterally at an angle of 12°to the center of the medullary canal. The tip of the guidewire should be centered in the medullary canal 20 mm distalto the lesser trochanter.

Verify that the guide wire position allows adequate clearanceon the lateral side of the femur for the opening drill bit.

The guide wire is inserted with it centered in the lateral view.



4Open proximal femur to medullary canal

Required set

150.060 Flexible Reamer Set for IM Nails

Instruments


351.27 13.0 mm Cannulated Drill Bit

351.706S 2.5 mm Reaming Rod, 950 mm



Drill to open cortexDrill through the protection sleeve. Drill the cortex until the drill bit stops in the sleeve.

Remove the guide wire, drill bit and protection sleeve.

Note: Dispose of the guide wire. Do not reuse.

If reaming the medullary canal, proceed to page 17.

Ream to open proximal femurInsert the 2.5 mm reaming rod. Using the flexible reamers,open the proximal femur to a depth of approximately 75 mm, starting with an 8.5 mm reamer and ending with a 13.0 mm reamer.

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75 mm



4Open proximal femur to medullary canal continued

Alternative technique (with awl)

Alternative instruments

03.010.041 14.0 mm Cannulated Awl


Place the cannulated awl over the guide wire and open themedullary canal. Use a twisting motion to advance the awl to a depth of approximately 75 mm.

Remove the guide wire and awl.

Note: After opening the proximal femur, dispose of the guidewire. Do not reuse.



5Ream medullary canal (optional)

Required set

150.060 Flexible Reamer Set for IM Nails

Instruments

03.010.024 Holding Device for Guide Wires and Reaming Rods

03.010.093 Reaming Rod Push Rod

351.706S 2.5 mm Reaming Rod with ball tip, 950 mm

351.707S 2.5 mm Reaming Rod with ball tip and extension, 950 mm

351.708S 2.5 mm Reaming Rod with ball tip, 1150 mm

351.782 Holding Forceps for Reaming Rods

360.251 7.5 mm Intramedullary Reduction Tool

393.105 Small Universal T-Handle Chuck

If necessary, enlarge the femoral canal with the medullaryreamer to the desired diameter.

Check fracture reduction under image intensifier. Use the 7.5 mm reduction tool to facilitate reduction.

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5Ream medullary canal (optional) continued

Insert reaming rodUsing the holding device or T-handle chuck, insert the reamingrod with ball tip into the medullary canal to the desired depth.

If using the holding device, set the thumb switch to the ‘RELEASE’ or ‘LOCK’ position (Figure 1).

RELEASE position: Clamp will free the wire upon releasingthe handle (Figure 3).

LOCK position: Clamp will retain the wire. The device willclick when set to the LOCK position.

Note: To release a wire retained in the LOCK position, applyforce to the lever on its lower end, then push the thumbswitch to the RELEASE position. This relaxes the engagementof the locking mechanism by deflecting the lever.

Insert the guide wire / reaming rod. Apply force to the lever as far from the pivot as possible (Figure 2).

Note: To bend reaming rods, insert the extension tip into‘Reaming Rod’ hole on the back of the handle. Bend untilthe rod contacts the handle. This allows a 15º bend on thereaming rod tip (Figure 4).


Figure 1 Figure 2

Figure 3 Figure 4


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Beginning with the 8.5 mm diameter reaming head, ream to a diameter of at least 1.0 mm greater than the nail diameter. Ream in 0.5 mm increments and advance thereamer with steady, moderate pressure. Do not force thereamer. Partially retract the reamer often to clear debris from the medullary canal.

The holding forceps can be used to control the rotation of the reaming rod.

Note: The reaming rod with ball tip can be removed throughthe cannulated adolescent lateral entry femoral nails. Reamingrod exchange is not required.




5Ream medullary canal (optional) continued

Option Use the reaming rod push rod to help retain the reaming rod during reamer extraction.


Inserting the Nail

1Assemble insertion instruments

Instruments

03.010.044 Cannulated Connecting Screw, for StandardInsertion Handle

03.010.092 Ball Hex Screwdriver, 8 mm

03.010.226 Insertion Handle for Adolescent Lateral EntryFemoral Nail–EX

Match the tangs on the handle to the notches in the Adolescent Lateral Entry Femoral Nail–EX.

Place the connecting screw into the insertion handle andthread it into the proximal nail end, using the 8 mm ball hex screwdriver.

The Adolescent Lateral Entry Femoral Nails–EX are labeled left or right on the proximal nail end.

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Inserting the Nail continued

1Assemble insertion instrument continued

Optional instrument

03.010.093 Reaming Rod Push Rod

Slide the connecting screw onto the reaming rod push rod.Slide the assembly through the insertion handle and matchthe tangs on the handle to the nail. Tighten using the hex on the reaming rod push rod.

Secure the assembly using the 8 mm ball hex screwdriver.



2Insert nail

Instruments

03.010.047 Driving Cap with Handle Adapter

03.010.056 Slide /Fixed Hammer, 700 grams


321.17 Pin Wrench, 4.5 mm

321.20 Ratchet Wrench, 11 mm

357.22 Hammer Guide

357.398 Cannulated Shaft with 8 mm hex

Slide the driving cap into the groove on the insertion handleand secure it using the 11 mm ratchet wrench. If patientanatomy allows, attach the driving cap in the medial position.

Orient the insertion handle in an anterior position. Use theC-arm to verify fracture reduction. Insert the nail as far as possible.

The nail rotates approximately 90° during insertion. The insertion handle rotates from an anterior to a lateral positionduring insertion of the last one-third of the nail length. If the nail does not rotate to the lateral position, remove thenail and reinsert it with the handle slightly lateral to the sagittal plane.

Monitor nail passage across the fracture, and control in twoplanes to avoid malalignment.

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Inserting the Nail continued


2Insert nail continued

If desired, insert the nail using light hammer blows.

Lock the head of the hammer in place by tightening the nutonto the threads located below the hammer head. Use thepin wrench if necessary. Strike the driving cap directly.

Optionally, the hammer guide can be threaded onto the driving cap and the hammer can be used as a slide hammer.Loosen the nut from the threads located below the hammerhead and secure the nut onto the threads located above the handle.

Note: Do not mount the aiming arm until the nail has beencompletely inserted.


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3Check proximal nail position

Insert the nail until it is at or below the femoral opening.Check final nail position under image intensification in AP and lateral views.

If primary compression or secondary dynamization is planned,it is recommended to overinsert the nail by more than 7 mm,which corresponds to the maximum distance between thepositions in static and dynamic modes.

Note: The distance between the markings on the insertionhandle is 5 mm and corresponds to the extensions of the endcaps. This feature can be used for overinsertion of the nail.

4Check distal nail location

Use image intensification to ensure the nail is centered in bothAP and lateral views. Verify fracture alignment.

Remove the reaming rod.


Locking Options


Proximal locking with 120° locking screw Proximal locking with recon locking


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Proximal locking with dynamization Proximal locking with static transverse locking screw


Proximal Locking—Standard


1Choose locking option

For standard locking, three targeted proximal locking optionsare possible:

1 120° antegrade locking

2 Dynamic locking (LM)

3 Static locking (LM)

For immediate dynamization, insert one proximal lockingscrew through the dynamic slot. If dynamization may be required in the future, use the dynamic locking option withthe 120° antegrade locking hole.

2Mount aiming arm

Instruments


03.010.227 Aiming Arm for Adolescent Lateral Femoral Nail–EX

Confirm that the nail is securely connected to the insertionhandle using the 8 mm ball hex screwdriver. Mount the aiming arm to the insertion handle.

1

2

3


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3Insert trocar assembly

Instruments

03.010.063 12.0 mm/8.0 mm Protection Sleeve, 188 mm

03.010.064 8.0 mm/3.2 mm Drill Sleeve, 200 mm

03.010.069 3.2 mm Trocar, 210 mm

Insert the three-part trocar assembly (protection sleeve, drillsleeve and trocar) through the desired hole in the aimingarm, make a stab incision and insert the trocar to the bone.Remove the trocar.

If using the 120° antegrade locking option, insert the trocarassembly through the hole labeled 120° on the insertion handle.

Note: Do not exert forces on the aiming arm, protectionsleeve, drill sleeves or drill bits. Such force may prevent accurate targeting through the proximal locking holes anddamage the drill bits.


Proximal Locking—Standard continued


4Drill and determine locking screw length

Instrument

03.010.060 3.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration

Ensure that the drill sleeve is pressed firmly to the lateral cortex.Drill through both cortices until the tip of the drill bit justpenetrates the far cortex.

Confirm drill bit position.

Ensure that the drill sleeve is pressed firmly to the lateral cortexand read the measurement from the calibrated drill bit at theback of the drill sleeve. This measurement corresponds to theappropriate length locking screw. Remove the drill bit anddrill sleeve.

Alternative instrument

03.010.072 Depth Gauge for Locking Screws

After drilling both cortices, remove the drill bit and drill sleeve.

Disassemble the depth gauge into two parts: the outer sleeveand the measuring device with hook. Insert the measuringdevice into the protection sleeve. Make sure that the hookgrasps the far cortex.

Ensure that the protection sleeve is firmly pressed against thelateral cortex.

Read the measurement from the back of the protectionsleeve, which indicates the appropriate length locking screw.


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5Insert locking screw

Instrument

03.010.107 StarDrive Screwdriver, T25, self-retaining

Insert the appropriate length locking screw through the protection sleeve using the StarDrive screwdriver. Verify locking screw length under image intensification.

The tip of the locking screw should not project more than 2 mm to 4 mm beyond the far cortex.

Note: A groove on the screwdriver provides a rough indicationthat the locking screw is fully inserted through the sleeve.

Repeat for a second proximal locking screw if desired.


Proximal Locking—Recon


1Confirm nail position

In the AP view, adjust the nail insertion depth to ensure thatthe two recon screws can be placed into the femoral head.

Adjust nail position for correct anteversion.

2Mount aiming arm

Instruments


03.010.227 Aiming Arm for Adolescent Lateral Femoral Nail–EX

Confirm that the nail is securely connected to the insertionhandle using the 8 mm ball hex screwdriver. Mount the aiming arm to the insertion handle.


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3Insert guide wires for recon screws

Instruments

03.010.075 11.5 mm/8.5 mm Protection Sleeve, for Recon Locking

03.010.076 8.5 mm/3.2 mm Wire Guide, for ReconLocking

03.010.077 3.2 mm Trocar, for Recon Locking

357.399 3.2 mm Guide Wire, 400 mm

Insert both three-part trocar combinations (protection sleeve,drill sleeve, and trocar) through the aiming arm. Make a stabincision and insert the trocars to the bone.

Following the arrows on the aiming arm, rotate the cams so that the protection sleeves are locked in the aiming arm.This will ensure proper measurement for the recon screws.

Remove the inferior trocar.


Proximal Locking—Recon continued


3Insert guide wires for recon screws continued

Insert a guide wire into the femoral head, stopping approxi-mately 5 mm from the subchondral bone. If the physis in thefemoral head is not fully arrested, stop the wire short of thephysis. Check the guide wire placement radiographically inboth planes.

Remove the superior trocar.

Insert the second guide wire into the femoral head, stoppingapproximately 5 mm from the subchondral bone. If the physisin the femoral head is not fully arrested, stop the wire shortof the physis. Check the guide wire placement radiographi-cally in both planes.

Note: Do not exert force on the aiming arm, protectionsleeves, or drill sleeves. Such force may prevent accurate targeting through the locking holes.


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4Determine length and drill for inferior recon screw

Instruments

03.010.079 Drill Stop

03.010.085 Specialty Locking Measuring Device

03.010.228 Drill Bit for 5.0 mm Recon Screws

Measure for the inferior screw.

Ensure the protection sleeve is pressed firmly to the lateralcortex. Remove the wire guide and insert the specialty measuringdevice over the guide wire, into the protection sleeve, and tothe bone. Read the length of the required recon screw directlyon the measuring device.

Remove the measuring device and the inferior guide wire.

Attach the drill stop to the stepped drill bit for the appropriatelength screw.

Guide the stepped drill bit through the protection sleeve to the bone. Drill to the stop.


Proximal Locking—Recon continued


5Insert inferior recon screw

Instrument

03.010.108 StarDrive Screwdriver, T25

Insert the appropriate recon screw through the protectionsleeve into the femoral neck using the long T25 StarDrivescrewdriver. Verify the position of the locking screw underimage intensification in both planes.

A groove on the screwdriver indicates when the lockingscrew is fully inserted.

6Insert superior recon screw

Repeat Steps 3 through 5 for the superior recon screw.


Distal Locking

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1Distal locking

There are two transverse distal locking holes.

2Align image

Check the reduction and correct alignment of the fragmentsand leg length before locking the nail.

Align the C-arm with the hole in the nail closest to the fractureuntil a perfect circle is visible in the center of the screen.


Distal Locking continued


3Determine incision point

Place a scalpel blade on the skin over the center of the hole to mark the incision point and make a stab incision.


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4Drill

Instrument

03.010.103 3.2 mm Three-Fluted Drill Bit, quick coupling, 145 mm

If using the standard freehand technique, insert the tip ofthe drill bit through the incision and down to the bone.

Incline the drive so that the tip of the drill bit is centered overthe locking hole. Hold the drill bit in this position and drillthrough both cortices.

Technique tip: For greater drill bit control, discontinue drillpower after perforating the near cortex. Manually guide thedrill bit through the nail before resuming power to drill thefar cortex.


03.010.100 3.2 mm Three-Fluted Drill Bit, quick coupling,145 mm, for Radiolucent Drive

Using the radiolucent drive under image intensification, insert the tip of the drill bit through the incision and down to the bone.

Incline the drive so that the tip of the drill bit is centered overthe locking hole. The drill bit should almost completely fillthe circle of the locking hole. Hold the drill bit in this positionand drill through both cortices.


Distal Locking continued


5Determine locking screw length

Instruments

03.010.100 3.2 mm Three-Fluted Drill Bit, quick coupling,145 mm, for Radiolucent Drive

03.010.103 3.2 mm Three-Fluted Drill Bit, quick coupling,145 mm

03.010.106 Direct Measuring Device, for Locking Screwsto 100 mm, for IM Nails

Stop drilling immediately after penetrating the far cortex.Disassemble the power drive or radiolucent drive from thedrill bit.

Ensure the correct position of the drill bit in regard to the far cortex of the femur.

Place the direct measuring device onto the drill bit. Read thegraduation on the measuring device at the end of the drillbit. This corresponds to the appropriate locking screw length.

Note: Drill bit location with respect to the far cortex is critical for measuring the appropriate locking screw length.


03.010.072 Depth Gauge, for locking screws to 100 mm, for IM nails

Measure the locking screw length using the depth gauge forlocking screws. Ensure the outer sleeve is in contact with thebone and the hook grasps the far cortex.

Read the locking screw length directly from the depth gaugeat the back of the outer sleeve.


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6Insert locking screw

Instruments


03.010.112 Holding Sleeve with Locking Device

Insert the locking screw using the screwdriver, and the holdingsleeve with locking device; if desired.

Verify locking screw length under image intensification. Thescrew tip should be about 2 mm beyond the far cortex. Ifneeded, a second locking screw may be inserted using thesame technique.

Use the holding sleeve as described below:Insert the holding sleeve onto the shaft of the screwdriverand place the tip of the screwdriver in the recess of the locking screw (Figure 1).

Push the holding sleeve in the direction of the locking screw.The sleeve now holds the locking screw.

Lock the holding sleeve by tightening it counterclockwise(Figure 2). After insertion of the locking screw, release the holding sleeve by loosening it clockwise and pulling itback (Figure 3).

Figure 1

Figure 2

Figure 3

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End Cap Insertion

7Insert end cap

Instruments

03.010.110 Cannulated StarDrive Screwdriver, T40

357.399 3.2 mm Guide Wire, 400 mm

Choose an end cap with the appropriate extension; 0 mm if the nail is not overinserted, 5 mm, 10 mm or 15 mm if the nail is overinserted.

The end caps are cannulated for use over a guide wire, if necessary.

Remove the nail insertion instruments.

Optionally, for insertion of the 0 mm end cap, remove theconnecting screw only. The insertion handle can remain tohelp align the end cap to the top of the nail. The 0 mm end cap fits through the barrel of the insertion handle.

Insert the guide wire into the proximal end of the nail.

Engage the end cap with the cannulated screwdriver by exerting axial pressure. To prevent cross-threading, align the end cap with the nail axis and turn the end cap counterclockwise, until the thread of the end cap aligns with that of the nail.

Turn the end cap clockwise to thread the end cap into the nail.

Remove the guide wire and screwdriver.


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Alternative instruments

03.010.111 Cannulated StarDrive Screwdriver, T40, with lever handle

321.20 Ratchet Wrench, 11 mm

The cannulated StarDrive screwdriver, T40, with lever handle,may be used with the 11 mm ratchet wrench to insert theend cap.


Implant Removal (Optional)


1Remove end cap and locking screws

Instruments


03.010.110 Cannulated StarDrive Screwdriver, T40

03.010.112 Holding Sleeve with Locking Device


Implant removal is an optional procedure.

Clear the StarDrive recess of the end cap and the locking implants of any ingrown tissue. Insert the guide wire for easyalignment of the screwdriver in the cannulated end cap. Remove the end cap using the T40 screwdriver.

Remove all locking screws except one proximal locking screw.

2Attach extraction screw and hammer guide

Instruments


357.133 Extraction Screw

357.22 Hammer Guide for Slide Hammer

Before removing the final locking screw, screw the extractionscrew into the nail and tighten it. The locking screw will prevent nail rotation as the extraction screw is tightened.

Attach the hammer guide to the extraction screw.

Remove the remaining locking screw with the screwdriver.


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3Remove nail

Instrument


Extract the nail by applying gentle blows with the hammer.

Note: The nail will rotate about 90°, similar to the movementduring the insertion.


Implant Specifications


Adolescent Lateral Entry Femoral Nail–EX– Available for left or right femur

– Anatomic nail design based on a femoral canal tracing study3

Material– Titanium-6% aluminum-7% niobium alloy

Diameters– 8.2 mm, cannulated

– 9.0 mm, cannulated

– 10.0 mm, cannulated

Lengths– 240 mm through 400 mm in 20 mm increments

Cross Section– Helical fluted

Proximal locking– Dynamization slot (LM)

– Static transverse locking hole (LM)

– 120° antegrade locking

– Two recon locking holes

Distal locking– Two transverse locking holes (LM)

3. L. Ehmke, et al.

20.6 mm36.25 mm

50 mm

7 mm

12.5 mmRecon locking

Static transverse

Dynamic transverse

120° antegrade

12 mm

42 mm

LM

LM


Implants

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Titanium Adolescent Lateral Entry Femoral Nails–EX,sterile

8.2 mm diameter

Length (mm) Right Left240 04.031.924S 04.031.925S

260 04.031.926S 04.031.927S 280 04.031.928S 04.031.929S 300 04.031.930S 04.031.931S 320 04.031.932S 04.031.933S 340 04.031.934S 04.031.935S 360 04.031.936S 04.031.937S 380 04.031.938S 04.031.939S 400 04.031.940S 04.031.941S

9.0 mm diameter



10.0 mm diameter



22536-J8377B_22536-J8377B 1/5/10 12:10 PM Page 47

Implants continued


5.0 mm Titanium Recon Screws, with T25 StarDrive recess (purple)◊

– Titanium alloy*

– Lengths: 50 mm–125 mm (5 mm increments)

– 3.2 mm core diameter

– Partially threaded

– Self-tapping, blunt tip

– T25 StarDrive recess for improved torque transmission and self-retention on screwdriver

Length (mm) Length (mm)

04.031.020 50 04.031.028 9004.031.021 55 04.031.029 9504.031.022 60 04.031.030 10004.031.023 65 04.031.031 10504.031.024 70 04.031.032 11004.031.025 75 04.031.033 11504.031.026 80 04.031.034 12004.031.027 85 04.031.035 125

◊ Available nonsterile or sterile-packed. Add “S” to catalog number to order sterile product.



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4.0 mm Titanium Locking Screws, with T25 StarDrive recess, for IM Nails (blue)◊

– Titanium alloy*

– Lengths: 18 mm–80 mm (2 mm increments)

– 3.3 mm core diameter

– Fully threaded

– Self-tapping, blunt tip

– T25 StarDrive recess for improved torque transmission and self-retention on screwdriver


04.005.408 18 04.005.440 5004.005.410 20 04.005.442 5204.005.412 22 04.005.444 5404.005.414 24 04.005.446 5604.005.416 26 04.005.448 5804.005.418 28 04.005.450 6004.005.420 30 04.005.452 6204.005.422 32 04.005.454 6404.005.424 34 04.005.456 6604.005.426 36 04.005.458 6804.005.428 38 04.005.460 7004.005.430 40 04.005.462 7204.005.432 42 04.005.464 7404.005.434 44 04.005.466 7604.005.436 46 04.005.468 7804.005.438 48 04.005.470 80




Implants continued


Titanium End Caps, with T40 StarDrive recess, for Adolescent Lateral Entry Femoral Nails–EX◊

– Titanium alloy*

– Protect nail threads from tissue ingrowth

– Cannulated to allow insertion over a guide wire

– T40 StarDrive recess

0 mmSits flush with end of nail

5 mm, 10 mm and 15 mm extensionsExtend nail height if nail is overinserted

Extension (mm)

04.031.000 004.031.001 504.031.002 1004.031.003 15




Synthes 51

Additionally Available Implants

Titanium Angular Stable Locking Screws, with T25 StarDrive recess, for intramedullary nails, sterile

– Titanium alloy*

– 4.0 mm ASLS screws, 26 mm–80 mm, are compatible withtitanium cannulated adolescent lateral entry femoral nails

– Fully threaded shaft with 3 diameters– D1: Provides purchase in reamed near cortex– D2: Expands sleeve, providing angular stability– D3: Holds unexpanded sleeve for screw insertion,

provides purchase in far cortex

– T25 StarDrive recess

– Sterile packaged

Resorbable Sleeves for Angular Stable Locking Screws,sterile

– 70:30 poly(L /DL-lactide)

– Bioresorbable polymer material gradually resorbs within 18–24 months1

– Inner thread for secure fit to ASLS screw

– Expands in nail’s locking hole to provide angular stability

– 4.0 mm sleeve for use with 4.0 mm ASLS screws

– Sterile packaged (2 per package)

Note: For more information, please see ASLS techniqueguide and brochure.

D1

D2

D3

1. Based on in vivo animal testing. In vivo animal testing may not necessarily be indicative of human clinical performance.




Instruments

03.010.020 Radiographic Ruler, for TitaniumCannulated Femoral Nails



03.010.024 Holding Device, for Guide Wires and Reaming Rods


03.010.044 Cannulated Connecting Screw, for Standard Insertion Handle


03.010.056 Slide/Fixed Hammer, 700 grams


Synthes 53

03.010.060◊ 3.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration

03.010.063 12.0 mm/8.0 mm Protection Sleeve

03.010.064 8.0 mm/3.2 mm Drill Sleeve

03.010.069 3.2 mm Trocar

03.010.072 Depth Gauge, for Locking Screws to 100 mm

03.010.075 11.5 mm/8.5 mm Protection Sleeve, for Recon Locking

03.010.076 8.5 mm/3.2 mm Wire Guide, for Recon Locking

◊ Available nonsterile or sterile-packed. Add ‘S’ to catalog number to order sterile product.


Instruments continued


03.010.077 3.2 mm Trocar, for Recon Locking

03.010.079 Drill Stop, for 4.5 mm/6.5 mm Stepped Drill Bit

03.010.085 Specialty Locking Measuring Device, for Titanium Femoral Recon Nail–EX


03.010.093 Reaming Rod Push Rod, with ball handle

03.010.103◊ 3.2 mm Three-Fluted Drill Bit, quick coupling,needle point, 145 mm

03.010.106 Direct Measuring Device, for Locking Screwsto 100 mm



Synthes 55


03.010.108 StarDrive Screwdriver, T25, self-retaining, long

03.010.110 Cannulated StarDrive Screwdriver, T40, self-retaining

03.010.111 Cannulated StarDrive Screwdriver T40, with lever handle, self-retaining

03.010.112 Holding Sleeve, with Locking Device

03.010.226 Insertion Handle for Adolescent Lateral EntryFemoral Nails–EX

03.010.227 Aiming Arm for Adolescent Lateral EntryFemoral Nails–EX


Instruments continued


03.010.228 Drill Bit for 5.0 mm Recon Screws, large, quick coupling


319.97 Screw Forceps

321.17 4.5 mm Pin Wrench, 120 mm

321.20 Ratchet Wrench, 11 mm width across flats

351.27 13.0 mm Cannulated Drill Bit, 300 mm


Synthes 57

357.133 Extraction Screw

357.22 Hammer Guide

357.393 3.2 mm Trocar, 172 mm

357.398 Cannulated Shaft with 8 mm hex, 125 mm

357.399 3.2 mm Guide Wire, 400 mm

360.251 7.5 mm Intramedullary Reduction Tool, 460 mm

393.105 Small Universal Chuck with T-Handle



Adolescent Lateral Entry Femoral Nail–EX Instrument Set (01.031.001)

Graphic Case

60.031.001 Graphic Case for Adolescent Lateral EntryFemoral Nail–EX Instruments

Instruments

03.010.020 Radiographic Ruler, for Titanium CannulatedFemoral Nails


03.010.024 Holding Device, for Guide Wires and Reaming Rods



03.010.044 Cannulated Connecting Screw, for StandardInsertion Handle, 2 ea.



03.010.060◊ 3.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration, 2 ea

03.010.063 12.0 mm/8.0 mm Protection Sleeve, 188 mm

03.010.064 8.0 mm/3.2 mm Drill Sleeve, 200 mm

03.010.069 3.2 mm Trocar, 210 mm

03.010.072 Depth Gauge, for Locking Screws to 100 mm

03.010.075 11.5 mm/8.5 mm Protection Sleeve, for Recon Locking, 2 ea.

03.010.076 8.5 mm/3.2 mm Wire Guide, for Recon Locking, 2 ea.

03.010.077 3.2 mm Trocar, for Recon Locking, 2 ea.

03.010.079 Drill Stop

03.010.085 Specialty Locking Measuring Device, for Titanium Femoral Nails–EX


03.010.093 Reaming Rod Push Rod, with Ball Handle

03.010.103◊ 3.2 mm Three-Fluted Drill Bit, quick coupling,needle point, 145 mm, 2 ea.

03.010.106 Direct Measuring Device, for Locking Screwsto 100 mm


Note: For additional information, please refer to package insert.


Synthes 59


03.010.108 StarDrive Screwdriver, T25, self-retaining, long

03.010.110 Cannulated StarDrive Screwdriver, T40, self-retaining

03.010.111 Cannulated StarDrive Screwdriver, T40, withlever handle, self-retaining

03.010.112 Holding Sleeve, with Locking Device

03.010.226 Insertion Handle for Adolescent Lateral EntryFemoral Nail–EX

03.010.227 Aiming Arm for Adolescent Lateral EntryFemoral Nail–EX

03.010.228 Drill Bit for 5.0 mm Recon Screws, large, quick coupling, 2 ea.


321.17 4.5 mm Pin Wrench, 2 ea.

321.20 Ratchet Wrench, 11 mm width across flats

351.27 13.0 mm Cannulated Drill Bit, 300 mm

357.133 Extraction Screw, for Titanium Femoral andTibial Nails

357.22 Hammer Guide

357.393 3.2 mm Trocar, 172 mm

357.398 Cannulated Shaft with 8 mm hex

357.399 3.2 mm Guide Wire, 400 mm, 10 ea.

360.251 7.5 mm Intramedullary Reduction Tool, 460 mm

393.105 Small Universal Chuck with T-Handle


60 Synthes Titanium Cannulated Adolescent Lateral Entry Femoral Nail

Adolescent Lateral Entry Femoral Nail–EX Implant Set (01.031.002)

Screw Rack

60.031.002.30Screw Rack for Adolescent Lateral EntryFemoral Nail–EX Implants

Instrument

319.97 Screw Forceps

Implants

4.0 mm Titanium Locking Screws◊, with T25 StarDrive recess,for IM Nails, 2 ea.


04.005.408 18 04.005.440 5004.005.410 20 04.005.442 5204.005.412 22 04.005.444 5404.005.414 24 04.005.446 5604.005.416 26 04.005.448 5804.005.418 28 04.005.450 6004.005.420 30 04.005.452 6204.005.422 32 04.005.454 6404.005.424 34 04.005.456 6604.005.426 36 04.005.458 6804.005.428 38 04.005.460 7004.005.430 40 04.005.462 7204.005.432 42 04.005.464 7404.005.434 44 04.005.466 7604.005.436 46 04.005.468 7804.005.438 48 04.005.470 80

5.0 mm Titanium Recon Screws◊, with T25 StarDrive recess,for IM Nails, 4 ea.


04.031.020 50 04.031.028 9004.031.021 55 04.031.029 9504.031.022 60 04.031.030 10004.031.023 65 04.031.031 10504.031.024 70 04.031.032 11004.031.025 75 04.031.033 11504.031.026 80 04.031.034 12004.031.027 85 04.031.035 125


Note: For additional information, please refer to package insert.

Titanium End Caps◊, with T40 StarDrive recess, 2 ea. Extension (mm)

04.031.000 004.031.001 504.031.002 1004.031.003 15


Also Available

Sets

01.025.002 Angular Stable Locking System Instrument Set

01.025.008 4.0 mm Angular Stable Locking System Screw Set

Instruments

03.010.100◊ 3.2 mm Three-Fluted Drill Bit, quick coupling,for Radiolucent Drive

351.706S 2.5 mm Reaming Rod with ball tip

351.707S 2.5 mm Reaming Rod with ball tip and extension

Implants

08.025.032S Resorbable Sleeve for 4.0 mm Angular StableLocking Screw, sterile (2 /pkg.)

Synthes



Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2008 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 1/10 J8377-B

www.synthes.com


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