ProximalFemurNailingSystem

SurgicalTechnique

www.carboͲfix.com
 Introduction
Implants
The Nail and Lag Screw are made of longitudinal continuous carbon fiber reinforced
polymer (PEEK). The screws are made of Titanium-alloy (Ti-6Al-4V).
Features of the CarboFix Proximal Femur Nailing System:
• Anatomically shaped ProximalFemurNail with a slight bend close to its proximal end
(M-L Bend) of 5 degrees, and a Caput-collum-diaphyseal angle (CCD) of 130 degrees.
• Lag Screw is intended for insertion through the Nail proximal screw-hole, into the
femoral head. It is available in varying lengths.
• The Proximal Femur nail is used in an antegrade approach.
For further information please refer to the product Instructions for Use.

The Nail and Lag Screw are supplied sterile.

Implants dimensions are as follows:
 
Proximal Femur Nail

LagScrew

6.85 10.4

Lag Screw Proximal Femur

Screws
Nail

SetScrew
The Piccolo Composite Proximal Femur Nail is provided with both a short
Set Screw ("Sliding Set Screw"), which eliminates Lag Screw rotation, but
allows sliding, and a longer Set Screw ("Locking Set Screw"), which also
limits Lag Screw sliding.

 

[A Retrograde Femoral Case]

Instrumentation

AccessGuideWire(Ø3.2mm)
Marks the entry point into the medulla canal, and the
trajectory.

Awl
Used to access the medullary canal for insertion of the
Nail. The Awl can be positioned over the Access Guide
Wire.

EntryPortal&EntryTrocar
The Entry Portal is a soft tissue protector used during soft
tissue tunneling and reaming.

The Entry Trocar is used for soft tissue tunneling at the

access point. It accommodates a Ø3.2mm Access Guide
Wire. The Trocar is locked to the Entry Portal by turning it
clockwise.

Ø17x300mmDrillBit
Used to access the medullary canal. It is to accommodate a
Ø3.2mm Access Guide Wire.
BallͲTipGuideWire(Ø2.5mm)
Assists in fracture reduction, reaming and medulla canal length
measurement. Compatible with conventional reamer sets. Ball
Tip diameter is 4.5mm.
Supplied sterile; packed separately, for single use.

GuideWireRuler
Measures the required nail length over the proprietary Ball-Tip
Guide Wire.

RadiographicRuler
Used to determine the required Nail diameter and length.

GuideWireExchangeTube
Used for replacing the Ball-Tip Guide Wire with the Ø2.5mm
Guide Wire.
Supplied sterile; packed separately, for single use.

GuideWire(Ø2.5mm)
The Ø2.5mm Guide Wire is used for Nail insertion into the medulla canal.
It may be supplied sterile; packed separately, for single use.
InsertionHandle
The Insertion Handle is connected to the Nail, and enables Nail
insertion

ConnectionTube
The Connection Tube connects and locks the Handle to the Nail
proximal end.

BallͲHexͲTipScrewdriver
Connects to the Nail Adapter for detaching the Insertion
Handle from the Nail. May also be used for connecting
and detaching the Lag Screw Insertion Handle from the
Lag Screw.

StrikingAdapter
Connects to the Insertion Handle. During Nail insertion, the
surgeon can tap on it using a Mallet, or connect it to the Slide
Hammer.


Mallet
The Mallet may be used during Nail insertion. The plastic side of the
Mallet should be used for tapping the Striking Adapter gently.

 
LagScrewSleeve,LagScrewKͲWireSleeve&LagScrewTrocar
The Sleeves provide working channel for Lag Screw insertion,
and accommodate a Ø2.85mm K-Wire and the Ø10.4mm Drill
Bit.
The Guide & Drill Sleeves lock to each other.


LagScrewKͲWireDepth(Ø2.85mm)
Marks the entry point and trajectory for Lag Screw insertion.
Supplied sterile; packed separately.


KͲWireDepthGauge
Measures the required Lag Screw length; for use with the Lag
Screw K-Wire.


DrillBits
There are several Drill Bits in the set:
• Ø10.4mmStepDrillBitfor drilling the hole for the Lag Screw.
• Ø4.2mm Step Drill Bit Ͳ Long (L: 365mm) for drilling the Distal
Screw hole through the Insertion Handle. It has markings along its
shaft for measuring the required screw length.
• Ø4.2mmStepDrillBitͲShort(L: 180mm) for free hand drilling of
the hole for the Distal Screw.

Tap
For Lag Screw hole tapping.
 
LagScrewDriver(LagScrewInsertionHandleAssembly)
A two-component insertion handle for the Lag
Screw, combined of an outer tube and an inner rod.
The driver distal end design prevents relative
rotation between the Lag Screw and the driver.

SlidingLimitDriver
An instrument designed to assess in limiting Lag Screw sliding. It is inserted
via the Connection Tube, to rotate a screw located within the Nail proximal
end.

DistalScrewGuide&DrillSleeve,DistalScrewTrocar
The Guide Sleeve is a working channel through
which the Drill Sleeve and the Trocar are inserted.
The Drill Sleeve accommodates the Ø4.2mm Drill
Bit.
The Guide & Drill Sleeves lock to each other.

FreeHandDrillSleeve
A working channel for Ø4.2mm Drill Bits. It is radiolucent and
is used for drilling, in free hand technique, the distal screw
hole(s).

 
DistalScrewDepthGauge
Used to measure the required Distal Screw length.

Screwdriver
Used to insert or remove the Screws and the Nail
Cap.

PowerDriveScrewdriver
For use with a power drive.


NailRemovalAdapter
For Nail removal; connects to the Nail proximal end as well as to
the Slide Hammer.


SlideHammer
Used for Nail removal by connecting it to the Nail Removal
Adapter. Optionally, it may be used for Nail insertion. In such
cases it is connected to the Striking Adapter.
 ProcedureSteps
Note:Theentireprocessshallbeperformedunderfluoroscopicvisualization.


Entry&Preparation
1. Makeskinincisionofapproximately2.5cmfromthegreatertrochantertowards
theiliaccrest.Achieveaccesstothebone.

2. UsetheØ3.2mmAccessKͲWiretomarktheentrypoint.

Therearetwowaystoenterthebone:
A. Use the Awl over the Access KͲWire to
perforateanentryhole.TheAwldiameteris
17mm,tofitthediameteroftheNail. 

B. InserttheEntryTrocarintotheEntryPortal,
andlockitbyrotatingitclockwise.





   
 InsertThePortalAssemblyovertheKͲWire,so
thattheKͲWirepassesthroughthecenterhole
oftheEntryTrocar;




Use the adjacent holes of the Entry Trocar in
ordertoimproveKͲWireposition,ifrequired:
ƒ RotatetheEntryTrocarsothattheholes
arelocatedasdesired.
ƒ InsertaKͲWirethroughthedesiredhole,
andremovetheonethatwasincorrectly
placed.

RemovetheEntryTrocar.

Use the Ø17mm Drill Bit over the KͲWire to
accessthebone.





3. For Long Nails Ͳ Insert the BallͲTip Guide Wire into the medulla canal past the
fractureline.Performreamingifdesired.TheBallTipGuideWirecanbeusedwith
anyconventionalintramedullaryflexiblefemoralreamingsystem,andaccording
toitsinstructionsforuse.TheGuideWireshaftdiameteris2.5mm,andtheBall
Tipdiameteris4.5mm.
Finalreamingshouldbe1–1.5mmlargerthantheselectedNaildiameter.

 
NailMeasurement(forLongNails)
4. MeasuretheFemurlengthanddiameterusinga
RadiographicRuler.
Optional: the required nail length can be
measured by using the Guide Wire Ruler. A
marker on the BallͲTip Guide Wire marks the
requirednaillength.


5. Use a Guide Wire Exchange Tube to exchange the BallͲTip Guide Wire by the
Ø2.5mmGuideWire,onwhichthenailwillbeinserted.



NailInsertion
6. Connect the Handle to the Nail proximal end using
theConnectionTube.
Make sure the protrusions on the Insertion Handle
match the grooves on the nail. Verify the nail is
orientedproperly.







 

TightentheConnectionTubetotheHandleusing
theBallHexTipScrewdriver.Donotapplyhigh
torque.


 




7. ConnecttheStrikingAdaptertotheHandle.




8. InserttheNailintothecanal,overtheGuideWire.
Ifneeded,theMalletcanbeusedtoinserttheNail.Usetheplasticpartofthe
MallettotapontheStrikingAdapter.

Important:Donotuseexcessiveforce.UseslightstrokesonlytopositiontheNail.
DonotuseoscillatingmovementstoinserttheNail.TapontheAdapteronly.
 
DuringNailinsertion,assurefracturereductionusing
fluoroscopy.

TheNailiscorrectlylocatedwithinthecanaloncethe
Nailproximalend(theareaofconnectionoftheNail
to the Insertion Handle, as can be seen using
fluoroscopy) is aligned with the tip of the greater
trochanter.

RemovetheGuideWire.



LagScrewInsertion
9. Make skin incision where Lag Screw hole is located,
andachieveaccesstothebone.

10. Place the Lag Screw Sleeve, with the KͲWire Sleeve
andKͲWireTrocarwithinit,insidethelagscrewhole
oftheHandle.LockthesleevestotheHandleusingthe
lockingknobontheHandle.



 Locking Knob

 
 
Remove the Trocar and insert a Ø2.85mm KͲWire
throughtheKͲWireSleeve.

Ensurethatthesleevesareincontactwiththelateral
cortex, while verifying the anatomic position under
fluoroscopy(APandLateralfluoroscopy):theKͲWire
shallbepositionedintheinferior1/3rdofthecervical
femur.


11. EvaluatetherequiredLagScrewlengthusingtheLag
ScrewDepthGaugeovertheKͲWire.




12. RemovetheKͲWireSleeve.

 13. UnderfluoroscopydrillaholefortheLagScrewusing
the cannulated Step Drill Bit over the Lag Screw KͲ
Wire.ThedistaltipoftheStepDrillBitshallgetasfar
astheLagScrewdistaltipshallbelocated.Verifythat
Stopper
thesleevesareincontactwiththebone.
AstopperprovidedontheDrillBitcanbesettothe
desireddrillingdepthbasedontheLagScrewlength

evaluation.

VerifytheLagScrewlengthaccordingtotheStep
DrillBitscale.ThedistalpartoftheStepDrillBitis
Length
markedwithlinesindicatingtheavailableLagScrew Indication

lengths, at 10 mm steps, with the most proximal

line corresponding to a 110 mm long Lag Screw.
RemovetheStepDrillBit.
 

Prepare the hole created for Lag Screw insertion

withthehelpofthecannulatedScrewͲTapoverthe
LagScrewKͲWire.

RemovetheScrewͲTap.


 
 14. ConnecttheLagScrewDrivertotheselectedLagScrew.AligntheLagScrewDriver
tubewiththerecessesattheLagScrewproximalend,androtateitsrodclockwise,
tothreaditintotheLagScrew.
The BallͲHexͲTip Screwdriver can be used for final tightening. Do not apply high
torque.



 



15. Insert the Lag Screw, through the Lag Screw
Sleeve, while verifying proper positioning of the
fracture.TheLagScrewDriverismarkedwithlines
indicatinginsertiondirection–makesureoneof
themarksisalignedwiththemarkontheHandle.












 
16. If desired – compaction may be performed;
rotate the knob on the Lag Screw Driver to
achievethedesiredcompaction.
Compactionofupto15mmcanbeachieved.





17. SelecttherequiredSetScrew.
UsetheSlidingLimitDrivertoinserttheSetScrew
throughtheConnectionTubeintothenailproximal
end.
GentlyrotatetheSetScrewwithintheNailproximal
endclockwisetoslightlytightentheSetScrew.

Remove the Lag Screw Driver by counterclockwise
rotationofitsrod.TheBallͲHexͲTipScrewdrivermay
beused.

RemovetheLagScrewSleeveandtheKͲWire.



DistalScrews
18. Make skin incision where Distal Screw hole is located, and achieve access to the
bone.

 
 FortheshortNails(180,200mmlength)–

19. PlacetheDistalScrewGuideSleeve,withtheDrillSleeveandTrocarwithinit,inside
theappropriateHandlehole.






AfterpositioningoftheSleeves,removetheTrocar.


20. Drill a hole for the Screw using the long Ø4.2mm
DrillBit.DrillBitgraduationmarksmaybeusedto
assessScrewlengthagainsttheDrillSleeve.









RemovetheDrillBitandDrillSleeve.



 21. Select the appropriate length of the Ø5.0mm
Screw, by using the Distal Screw Depth Gauge
and/ortheDrillBitgraduationmarks(asindicated
above).


22. InserttheScrewthroughtheGuideSleeve,by
using the Screwdriver (Power Screwdriver
couldalsobeused).


RemovetheScrewdriverandGuideSleeve.
 


Note:Alternatively,“freehand”drillingmaybeperformed;insuchcase,Please
Followthenextsteps.

FortheLongNails(300–460mmlength)–
23. Distaldrillingisperformedin“freehand”technique.

Tinytantalumrodsmarkers,locatednearthedistalholes,assistinlocatingthe
centeroftheholes.
 Uponproperpositioning,whilethexͲraybeamisperpendiculartothehole,the2
radiopaquemarkersateachsideoftheholeshouldbealignedintoasingledot.In
properpositioningasingledotshouldbeseenateachsideofthehole.

Radiopaque Holefor Radiopaque Holefor

 Markers Screw Markers Screw




X ¥

IncorrectAlignmentofMarkersfor Correct AlignmentofMarkersforDistal
 DistalScrewsInsertion ScrewsInsertion



DrillaholefortheInterlockingScrewusingthe
short Ø4.2mm Step Drill Bit through the Free
HandDrillSleeve,infreeͲhandtechnique.



24. SelecttheappropriatelengthoftheØ5.0mmScrew,byusingtheDistalScrewDepth
Gauge.

25. InserttheScrewbyusingtheScrewdriver(PowerScrewdrivercouldalsobeused).


NailCapInsertion
26. RemovetheConnectionTube(counterclockwise
rotation)anddisconnecttheHandlefromthe
Nail.


27. The Nail Cap shall be inserted by using the
Screwdriver.
There are 3 available Nail Cap lengths: 0, 5 &
10mm.

The Nail Cap incorporates two embedded radiopaque markers for visualization
underfluoroscopy.


28. Closethebonepenetrationpointsaccordingtothesurgicalprocedure.
NailRemoval
1. Makeskinincisionandexposetheboneentryhole.

2. ConnecttheScrewdrivertotheNailCapattheNailproximal
end,andremovetheCapbycounterͲclockwiserotation.

3. UsetheSlidingLimitDrivertoreleasetheLagScrew–rotate
theSetScrewcounterclockwise.

4. MakeskinincisionwherethedistalScrewislocated.Usingthe
Screwdriver,removetheScrewbycounterͲclockwiserotation.

5. MakeskinincisionwheretheLagScrewislocated.Connectthe
LagScrewDrivertotheLagScrewandremovetheLagScrew
bycounterclockwiserotation.

6. ScrewtheNailRemovalAdapterontothenail’sproximalend.

7. ConnecttheSlideHammertotheNailRemovalAdapter.
UselightstrokesoftheSlideHammertoremovetheNail
fromthebone.

8. Closethepenetrationpointsaccordingtothesurgical
procedure.



 www.carboͲfix.com
Fordetailedprocedure,indications,contraindications,possibleadverseevent,warningsandprecautions,refertotheInstructionsforUse

Caution:IntheU.S.A.,federallawrestrictsthisdevicetosalebyorontheorderofaphysician.
1

MANUFACTURED BY: U.S.A.OFFICE: ECAUTHORIZED REPRESENTATIVE:

CarboFix OrthopedicsLtd. CarboFix OrthopedicsInc. MEDNETGmbH

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Ver.002_04͘2016

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Tel:+972Ͳ9Ͳ9511511 Tel:1Ͳ800Ͳ408Ͳ0120
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