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SU RG I C A L T ECH N I Q UE

Contents

U.S. Surgeon Design TeamGeorgeJ.Haidukewych,MD

Orlando, FL

DanielS.Horwitz,MD

Salt Lake City, UT

FrankA.Liporace,MD

Newark, NJ

S.AndrewSems,MD

Rochester, MN

FeaturesandBenefits 2

IndicationsandPre-opPlanning 7

PatientPositioningandReduction 8

EntryandCanalPreparation 9

NailInsertion 12

ProximalLocking 15

DistalLocking 23

EndCapPlacement 25

ImplantRemoval 26

ImplantDiagrams 27

ProductOrderingInformation 28

1

International Surgeon DesignerPeterGiannoudis,MD

Leeds, UK

Affixus™ HipFractureNail

2

3

strength and stability intheproximalfemur

•Optimallagscrewdesignforresistancetocut-out

•Easy-to-useinstrumentationandtargetingjig,

whichincludesGoalPost™technology,aidsin

lagscrewplacement

•Extensiverangeofneck/shaftangles,distaldiameters,

andnaillengths–combinedwithasmallproximal

naildiameter–allowsthesurgeontoachievea

closematchforeachpatient’sanatomy

•Uniquedistalbendfacilitatesentrythroughthe

proximal1/3ofthefemurandreducespotential

foranteriorcortexpenetration

Asystemofchoicesforeffectivetreatmentofproximalfemoralfractures

• Short(180mm)andlong(260-460mm)nailoptionstreatawiderangeofproximalfractureindicationsusingasinglesetofuser-friendlyinstruments

• 15.6mmproximalnaildiameter

• Proximal4˚lateralbendallowsforgreatertrochantericentrysite

• 125̊and130 ̊neckanglesprovidearangeofanatomicaloptions

• 10˚ofproximalanteversionbuiltintothenails

• 10.5mmdiametercannulatedlagscrewforbonepreservation

• Uniquethreadspacinganddesignofthelagscrewhelpstoresistdisplacementandcut-out

• Chamferonthefrontdistaltipfacilitates insertionanddecreasesriskofstresson theanteriorcortexinthedistalfemur

4

• 3°distalbendfacilitateseaseofinsertionthrough theproximalintertrochanteric/subtrochantericregion

• Pre-loadedsetscrewforeaseofuse

• 5.0mmanti-rotation(AR)screwforrotationalcontrol(optional)

• ShoulderedlagscrewandARscrewhelppreventmedialscrewdisengagement

• Longnailmaintainsa1.8Mradiusofcurvaturetocloselymatchthefemoralanatomy

• 5.0mmdiameterdistalinterlockingscrewshavealargecorediameterforstrongfixation

• Staticordynamicdistallockingoptionswitha6mmdynamizationrange

Multiplelockingoptionsforoptimalimplantstability

5

TheAFFIXUSHip FractureNail System, comprisedof short and longnails, provides surgeonswith

an intramedullaryhipscrewtostabilize fracturesof theproximal femur.TheAFFIXUSHipFracture

Nailcombines theprinciplesofacompressionhipscrewwiththebiomechanicaladvantagesofan

intramedullarynail.

Figure 1

*Systemincludesshort(180mm)andlong(260-460mm)nails,in20mmincrements.

Indications and Pre-op Planning

AFFIXUSHipFractureNailShort–(180mm)

Indications

7

AFFIXUSHipFractureNailLong–(260-460mm)

TheAFFIXUSHipFractureNailSystem*isdesignedforantegrade

trochantericinsertiontotreatthefollowingfractures(Figure1):

TheAFFIXUSHipFractureNailSystemisintendedtotreatstableand

unstableproximalfracturesofthefemurincludingpertrochanteric

fractures,intertrochantericfractures,highsubtrochantericfractures

andcombinationsofthesefractures,includingnon-union,malunion

andtumorresections.TheLongNailsystemisadditionallyindicated

totreatpertrochantericfracturesassociatedwithshaftfractures,

pathologicfracturesinosteoporoticbone(includingprophylactic

use)ofthetrochantericanddiaphysealareas,impending

pathologicalfractures,longsubtrochantericfractures,ipsilateral

femoralfractures,proximalordistalnon-unions,malunions,revision

proceduresandtumorresections.

Note: Bone screws referenced in this material are not intended

for screw attachment or fixation to the posterior elements

(pedicles) of the cervical thoracic or lumbar spine.

Patient Positioning and Reduction

Preoperative Planning, Continued

Placethepatientinthesupineorlateralposition

onafracturetableorradiolucentimagingtable.

Lateralaccesstotheproximalfemurisrequired.

IntraoperativeimageintensificationwithaC-arm

isrequiredtoobtainAPandlateralimagingof

theoperativeareaduringpreoperativepreparation

(reduction)andthroughouttheprocedurefornail

insertion,naillocking,andanteversionalignment.

Avoidexcessiveabductionofthehipduring

reductionastheaccesstothestartingpointand

nailinsertionmaybeimpeded.Thetrunkmay

belaterallyflexedawayfromtheoperativeside

toimproveaccesstothestartingpoint.The

contralaterallegmaybeflexedatthehip

orscissoredbelowtheaffectedleginthe

supineposition(Figure2).

Closed Fracture Reduction

Fluoroscopymustbeusedtoverifyproper

fracturereduction.

•Acceptablefracturealignmentmustbeobtained

priortoimplantinsertion

•Surgeonmustavoidvarusmalreductions

•Useacombinationoftraction,rotation,

adduction,andflexion/extensionoftheleg

toobtainanacceptablereduction

•Openreductionsmayberequiredformore

complicatedfracturepatternsandshouldbe

usedwhenanacceptableclosedreduction

cannotbeobtained(seepage10)

Initial Incision

Makeanincisionproximaltothetipofthegreater

trochanterinlinewiththefemoralaxis.Dividethe

fascialatainlinewithitsfibersandaccessthetip

ofthegreatertrochanter.

Figure 2

8

Awl

Figure 5 Figure 6

Trochantericentrypoint

Figure 3

Entryreamershapematchesproximalnailshape

Figure 4

9

Femoral Entry Preparation

Attachthestandard3.2mmguidepintothe

pistolguidewiregripper(Cat.No.2810-01-001)

orpowersourceandpassitthroughthetipofthe

greatertrochanterintothecenterofthefemoral

canal.Positiontheentryonthetipofthegreater

trochanter(Figure3).ConfirmonAPandlateral

fluoroscopyviewsthattheentrypiniscentered

onthetrochanter.

Option 1:

Cannulated Entry Reamer (One-step 16.6 mm)

Attachthecannulatedentryreamer(Cat.No.

2112-01-102or2112-01-103)tothepowersource

andpassitovertheguidepinthroughthe

entryportal(Figure4).

Itisessentialtoreamuntilthereamer’sproximal

shaftpasseswiththegreatertrochanter’scortical

boneastheshapeoftheentryreamermatchesthe

nailshapeandthetopofthecylindricalsegment

ofthereamercorrespondstothetopofthenail

(Figure4).Reamingshouldcontinueuntilthetip

oftheentryreamerisatthelevelofthelesser

trochanterandnotbeyond.

Option 2:

Cannulated Awl

Passthecannulatedawlovertheguidepinand

introducewitharotationmotionuntiltheawlis

buriedtoatleasthalfitsbladelength

(Figure5&6).

Entry and Canal Preparation

Open Fracture Reduction

Onceaccesstothefemoralcanalhasbeengained,

placetheballnoseguidewireintotheentrysite

utilizingthepistolguidewiregripper(Cat.No.

2810-01-001)(Figure7).

Obtainappropriateanatomicreductioninorder

torestorelength,anatomicaxisalignment,and

rotationoftheinjuredlimb.Reductioncanbe

achievedthroughthesurgeon’spreferredmethod

suchastraction,externalfixator,externalaids,

orjoysticks.Toaidinmanipulatingthefracture

fragmentsandpassingtheballnoseguidewire,

long(7.5mmdiameter,Cat.No.2810-01-007)and

short(6.5mmdiameter,Cat.No.2810-01-008)

reductiontoolsareavailable.

Insertthereductiontoolintothemedullarycanal,

pastthefracturesite.Oncethefractureisin

alignment,passtheballnoseguidewire,available

inboth80cm(Cat.No.2810-01-080)and100cm

(Cat.No.2810-01-100)lengths,acrossthefracture

site.Removethereductiontool(Figure8).


Figure 7

Figure 8

10

Canal Preparation

Short Nail

Confirmthatthefemoraldiaphysisiswideenough

andlongenoughtoallowtheselectednail

diametertopass.Reamasnecessarytoenlarge

thediaphysistoaccepttheselectednail.

Long Nail

Achieveproperalignmentoftheinjuredlimb

priortoreaming.Maintainalignmentthroughout

thereamingprocesstoavoideccentricreaming.

Commencereamingbyplacingtheflexiblereamer

overtheballnoseguidewire(Figure9).

Reamthemedullarycanalinmillimeterincrements

untilcorticalboneisreachedandinhalf-millimeter

incrementsthereafter.Surgeonpreferenceshould

dictatetheactualextentofintramedullaryreaming.

Monitorthereamingprocedureusingimage

intensificationtoavoideccentricorexcessive

corticalreaming.

Note: It is recommended to over-ream

the diaphysis by 2 mm.

Nail Length Selection

Withthetipoftheballnoseguidewireatthe

levelofthedesireddepthofnailinsertion,slideor

snapthenaildepthgauge(Cat.No.2112-01-106)

ontotheballnoseguidewireuntilitcontactsthe

bone,ensuringthatthetipdoesnotfallintothe

existingtrochantericentrycanal,thusprovidingan

inaccuratemeasurement.Toobtaintheappropriate

naillength,readthemeasurementmarkonthe

naildepthgaugethatisclosesttothebeginning

oftheblacktransitionareaontheguidewire

(Figure10).Ifanailoftheexactmeasuredlength

isnotavailable,chooseashorternailofthenext

closestavailablelength.Adirectmeasurement

canalsobetakenoftheuninjuredextremityusing

eitherradiographswithmagnificationmarkers,

ordirectlyontheuninjuredlimb.


Figure 9

Figure 10

11

Alignmentofproximal

targeting

Figure 11

Figure 12

Nail Insertion

12

Jig Assembly

Selecttheappropriatetargetingjigthatcorresponds

totheneckshaftangleoftheimplantselected.Insert

thejigboltthroughthetargetingjigusingthejigbolt

driver(Cat.No.2810-13-037or2810-13-006)

(Figure11).

Note: 130º neck angle is most commonly used

(Figure 12).

13

Nail Insertion

Figure 13A

Figure 13B

NailSlot

JigTab

Jig Assembly, Continued

Whenassemblingthenailtotheinsertionjig,

ensurethatthejigtabsalignwiththeslotsonthe

nailsothatthenailfullyseatsinthetargetingjig

(Figure13A).Oncethenailisfullyseated,

securelytightenthejigboltusingthejigbolt

driver(Cat.No.2810-13-037or2810-13-006)

Note: If it is difficult to attach the nail to the

jig, double-check that the nail and jig are

labeled with the same angle. The nail will

only align with the jig if they have the same

neck-shaft angle.

Checktheassemblypriortonailintroduction.Pass

thelagscrewsheaththroughthetargetingjig.A

properlyassemblednailandjigwillallowthelag

screwdrilltobedirectedthroughthesleeveand

throughthecenterofthelagscrewholeinthenail.

Whenusingashort(180mm)nail,confirmthe

targetingalignmentofthedistalinterlockingscrews

usingthegreensheathsanddrillbitsinthesame

manner(Figure13B).

Alignmentofdistaltargeting

Nail Insertion

Insertthenailbyhandoverthe3mmballnoseguide

wireintothemedullarycanal.Take care not to strike

the jig or targeting arm with the mallet.Acurved

impactiontool(Cat.No.2112-01-204)isincludedin

thesetandismeanttobeusedforgentletapsof

themallettofinetunethefinalseatingofthenail.

Note: The insertion jig should not be

hammered on.

Itmaybehelpfultopreliminarilyinsertthe

trochantericnailutilizingitsbowtofacilitate

clearanceofthemedialfemoralcortexofthe

proximalfragment.Todothis,rotatetheinsertion

jiganteriorly(towardtheceiling).Inthispositionthe

distalbendinthenailwillbeangledlaterallytoaid

inpassingthenailthroughthegreatertrochanteric

entrysite,andavoidmedialcorticalpenetration.

Asthenailpassesthemedialcortexoftheproximal

fragment,slowlyderotatethejighandleintothe

usuallateralposition,sothattheanteriorbowof

thenailnowcorrespondswiththeanteriorbowof

thefemur(Figure14).Ifthenailrequiressubstantial

forcetoadvance,removeitandreamanadditional

millimeter.Avoidexcessiveforcewheninsertingthe

nail.Advancethenailuntilthelagscrewalignstothe

desiredpositionintothefemoralheadandneckto

allowidealplacementofthelagscrew(Figure15).

Maintenanceofreductionmustbeconfirmedpriorto

lagscrewinsertion.Ifthereductionhasshiftedtoa

suboptimalposition,furtherhipadduction,traction,

androtationaladjustmentscanbemadepriortolag

screwplacement.Removetheballnoseguidewire.

Nail Insertion

Figure 14

Figure 15

14

15

Lag Screw Guide Pin Introduction

Insertthelagscrewsheathassembly

(lagscrewsheath–Cat.No.2112-01-300,

lagscrewtrochar–Cat.No.2112-01-301,

lagscrew3.2mmsleeve–Cat.No.2112-01-

302)throughthelagscrewholeinthejig.Pass

thetrocharthroughthesheathandmakean

appropriateskinincisionwherethetrocharcontacts

theskin.Advancethetrocharthroughthetissue

untilthetipisseatedagainstthelateralfemoral

cortexandconfirmwithfluoroscopy.Thetrochar

maybeimpactedintothelateralcortexwitha

mallettocreateastartingpointfortheguide

pinandminimizemigrationduringinsertion

(Figure16A).

Removethetrocharandmaintainthelagscrew

sheathpositionagainstthelateralfemoralcortex.

Note: At the distal end of the jig assembly,

the jig knob can be tightened to secure the

position of the lag screw sheath to maintain

contact against the lateral femoral cortex.

Introducethe3.2mmguidepinintothe3.2mm

sleeveanddrillintopositionunderfluoroscopic

guidance.Checktheguidepinpositionwithin

thecenterofthefemoralheadandneckinboth

APandlateralplanes.Advancetheguidepinto

adistancewithin5mmfromthesubchondral

bone(Figure16B).

Note: If at any time a guide pin is bent, replace

it immediately.

Proximal Locking

Figure 16A

Figure 16B

LagScrewSheath

LagScrew3.2mmsleeve

LagScrewTrochar

Goal Post™ Technology

TheGoalPostTechnologyisdesignedtofacilitate

visualizationofthefemoralneckonthelateralview

inordertomoreaccuratelyplacetheguidepin

forthelagscrew.Theanteriorandposteriormetal

postsontheproximalaspectoftheinsertionjig

allowforanunobstructedfluoroscopicviewdown

tothebaseofthefemoralneck(Figure17)and

assistwithfinetuningoftheguidepinbeforeit

isfullyseatedinthefemoralhead.

Lag Screw Length Selection

Beforeselectingalagscrewlength,verifythatthe

lagscrewsheathand3.2mmsleeveareinplace

andfullyseatedagainstthelateralfemoralcortex.

•Thedepthgaugeseatsagainstthelagscrew

sheath,notthe3.2mmsleeve

•Thesystemmeasurestothetipofthe

guidepin

•Themeasurementrepresentsthelengthofa

lagscrewthatbeginsattheendofthelag

screwsheathandterminatesatthetipof

theguidepin(Figure18)

16

Figure 18

Proximal Locking

Figure 17

Flouroscopictruelateraloftheproximalfemurwithinsertionjig

17

Depth Stop Adjustment

Adjustthedepthstoponthelagscrewdrill

(Cat.No.2112-01-303)tothedesireddepth.

Themeasurementonthedepthstopshouldbe

settothedepthmeasuredbythelagscrew

depthgauge(Cat.No.2112-01-304)(Figure19A).

Adjustthedepthstopbypushinginthebutton

andslidingthestopforwardorbackwarduntil

desiredepthisseenontheendofthedepth

stopclosesttothegolddrillbittip(Figure19B).

Note: There is a “notch” on the lag

screw drill that is visible under fluoroscopy; this

“notch” references 100 mm

(Figure 19A).

Lag Screw Drilling and Tapping

Advancethelagscrewdrillovertheguidepin

anddrilltothedesireddepth.Usefluoroscopyto

confirmthepositionofthelagscrewdrillandthat

theguidepinisnotadvancedintothehipjointor

acetabulumbythedrill.

Iftheboneisparticularlydense,usethecannulated

tap(Cat.No.2112-01-310)tocutathreadfor

thelagscrew.

Note: There is a guide pin repositioning tool

(2112-01-312) to aid in reinserting the guide

pin if it backs out with removal of the lag

screw drill.

Figure 19A

Measurementstakenhere,i.e.,100mm

Pushbuttoncontrol

Figure 19B

LagScrewDrill

CutOut

DepthStop

Proximal Locking

Lag Screw Insertion

Insertthelagscrewcouplingrod(Cat.No.2112-

01-306)throughthelagscrewdriver(Cat.No.

2112-01-307)andpositiontheselectedlagscrew

ontheendofthelagscrewdriver.Tightenthe

couplingrodtosecurethelagscrewtothedriver.

Advancethelagscrewmanuallyintothefemoral

neckandheadovertheguidepin.Confirmthe

terminalpositionofthelagscrewwithfluoroscopy,

withagoalofseatingthescrewbetween5and

10mmfromthesubchondralbone.

Thehandleofthelagscrewdrivermustbe

positionedeitherparallelorperpendiculartothe

targetingjigwhenthelagscrewhasbeenadvanced

tothedesireddepth(Figure20).Thiswillensure

thatthesetscrewwillengageoneofthegrooves

ofthelagscrew.

Fracture Compression

Compressionoftheintertrochantericcomponentof

thefracture,ifdesired,canbeachievedbyutilizing

thecompressionwheel(Cat.No.2112-01-308).

Oncethelagscrewhasbeenfullyseated,release

tractionfromthelegandfirmlyseatthelagscrew

sheathagainstthelateralcortex.Confirmthatthe

sheathistightlysecuredinthejigbytighteningthe

jigknob,andplacethecompressionwheelonthe

lagscrewdriverandadvanceagainstthelateralside

ofthesheath.Inosteoporoticbone,careshould

betakentoavoidpullingthelagscrewoutofthe

femoralheadwiththistechnique(Figure21).

Note: Hash marks on lag screw driver represent

5 mm intervals. It is recommended that no

more than 4-6 mm of compression is applied

and should be applied prior to placing the

Anti-Rotation (AR) screw.

Figure 21

Figure 20

18

Proximal Locking

19

Lag Screw Fixation

Thesetscrewispre-loadedinthenail.Usingthe

5mmsetscrewhexdriver(Cat.No.2112-01-309),

engagethesetscrewandadvanceinaclockwise

direction2to3fullrotationsuntilthesetscrew

contactsthelagscrewinoneofthefourlagscrew

grooves(Figure22a&22b).

Toconfirmproperpositionofthesetscrew,gently

attempttorotatethelagscrewbothclockwiseand

counterclockwise.Ifthereisfirmresistanceandthe

lagscrewwillnotrotate,thesetscrewhasproperly

engagedthelagscrewgrooves.However,ifyouare

abletorotatethelagscrew,thesetscrewhasnot

engagedagrooveandthelagscrewhandleshould

berealignedandthesetscrewtightenedagain.

Thesetscrewmaybebackedoffone-quarterturn

toallowdynamiccompressionofthelagscrewin

thenail,whilestillprovidingrotationalcontrolof

thelagscrew.

Note: The set screw can be engaged before or

after inserting the AR screw (if the AR screw is

to be used). The AR screw will align through an

oblong hole within the set screw.

Figure 22a

Figure 22b

Proximal Locking

Crosssectionofsetscrewengaginglagscrew

Figure 27

20

Anti-rotation (AR) Guide Pin and Screw Placement (optional )

Thissystemallowsmultipletechniquesfor

placementofananti-rotation(AR)screwifdesired.

•TheARscrewmaybeinsertedeitherbeforeor

afterthelagscrewisplaced,basedupon

surgeonpreferenceandthefracturepattern.

• Thesurgeonhastheoptiontoplaceaguide

pinthroughtheARholetoprovisionallystabilize

thefractureduringlagscrewplacement,or

he/shemaychoosetouseanARscrew.

TheguidepinusedthroughtheARholeisalso

usefultoassistinstabilizingthefemoralneck

andheadsegmentduringlagscrewplacement

toresistrotationaroundtheaxisofthefemoral

neck.Oncethelagscrewhasbeenplacedand

secured,thesurgeonmaychoosetoremovethe

guidepinfromtheARholeandplaceascrewin

thispositiontoprovidefurtherrotationalcontrol.

PlacetheARscrewsheath(Cat.No.2112-01-501)

andtrochar(Cat.No.2112-01-502)throughthe

ARholeintheinsertionjig.Makeasmallincision

wherethetrocharmeetstheskinandadvancethe

trochartothelateralaspectofthefemoralcortex.

Alternatively,incaseswherethelagscrewhas

alreadybeeninserted,extendtheincisionforthe

lagscrewproximallytoallowtheARscrew

sheathandtrochartobeseatedagainstthe

femur(Figure27).

Note: When the anti-rotation and lag screw

sheaths are seated at the same time, they must

be rotated so the groove on the lag screw

sheath faces the anti-rotation screw sheath

(so the colored handles are 180 degree to each

other) in order to allow both sheaths to fully

seat (Figure 27).

Proximal Locking

RemovethetrocharandinsertthetheAR3.2mm

sleeve(Cat.No.2112-01-503).Insertthe3.2mm

guidepinandadvanceintodesiredposition.Itis

recommendedtoleavetheARguidepin15-20

mmfromthesubchondralbone(Figure28).

Note: In cases where very dense cortical bone

is encountered, the cortex may be opened

up with the anti-rotation screw drill prior

to advancing the 3.2 mm guide pin to prevent

the guide pin from “walking” up the

lateral cortex.

Removetheguidepinand3.2mmsleeve.Confirm

thatthescrewsheathisadvancedagainstthe

lateralfemoralcortexandusetheARdrilltodrill

tothedesireddepth.Measurethelengthofthe

desiredscrewbyreadingthedepthoftheARdrill

againstthescrewsheath.

Note: It is recommended that the tip of the

AR screw be 15-20 mm shorter than the lag

screw to avoid perforation of the femoral

head (Figure 29).

Figure 29

Figure 28

15–20mm

5–10mm

21

Proximal Locking

22

SelectanARscrewofthedesiredlength.Place

theARscrewonthe3.5mmhexdriver(Cat.No.

2112-01-504)andmanuallyinsertthescrewinto

thefemurthroughtheARscrewsheath.

Advanceuntilthetipofthescrewreachesthe

desireddepthandconfirmwithfluoroscopy.The

screwdriverandsheathmaynowberemoved.

Securing the AR Screw (optional )

TheARscrewmaybesecuredwithanimpinging

incapthatisinsertedthroughtheendofthenail.

Note: The impinging in cap will make the AR

screw a static construct and is recommended to

only be used when the lag screw is also fixed

in a static position (this can be achieved by not

backing off the pre-loaded set screw a quarter

turn). Otherwise there is risk of creating the

Z-effect.

It is recommended to only lock the AR screw

in instances in which the set screw has been

left fully engaged into the lag screw, thus

preventing any collapse of the 10.5 mm

compression screw (Figure 30).

Theimpingingincapmaybeutilizedattheendof

thecase,afterthesetscrewforthelagscrewhas

beentightened,andtheinsertionjighas

beenremoved.

Figure 30

Proximal Locking

23

Distal Locking

Figure 23

Figure 24

Distal Locking (short nails)

Theshortnailmaybelockedeitherstatically,dynamically,

orleftunlockedbasedontheparticularfracturepattern

andstability(Figure23).

Passthedistalscrewsheath(Cat.No.2112-01-401)and

trochar(Cat.No.2112-01-402)throughtheholelabeled

“static”ontheinsertionjigandadvancetothelateral

femoralcortex.Removethetrocharandusethedistal

screwdrillsleeve(Cat.No.2112-01-403)and4.3mm

graduateddrillbit(Cat.No.2112-01-405).Drilluntil

thefarcortexiseitherreachedorpenetrated.Thedrillis

calibratedandmaybeusedtodeterminescrewlength

byreadingthedepthofftheendofthedistalscrewdrill

sleeve(Figure24).

Anoptionaldistalscrewdepthgauge(Cat.No.2112-

01-404)isavailabletoconfirmscrewlength.Thisgauge

measuresoffofthelateralsideofthe4.3mmdistal

screwdrillsleeve(Cat.No2112-01-403).

Selecta5.0mmdiameterscrewofthedesireddepth

andusethesolidlokscrewdriver(Cat.Nos.2810-01-020,

2810-01-021,2810-01-019)or3.5mmhexdriver

(Cat.No.2112-01-409)tointroducethescrewthrough

thescrewsheathandadvanceuntilitisfullyseated

againstthelateralcortex.

Repeattheabovestepsfordynamiclocking,exceptpass

thedistalscrewsheathandtrocharthroughthehole

labeled“dynamic”ontheinsertionjig.

Note: Maintain contact of the drill sheath on

the lateral femoral cortex to ensure accurate

measurement of the distal locking screw.

Verify screw position using AP and lateral

fluoroscopy imaging.

Note: There are two 4.3 mm drill bits available. Use the long bit (Cat. No. 2112-01-405) when drilling through the jig assembly and use the short bit (Cat. No. 2112-01-406) when performing the freehand approach.

Distal Locking

24

Figure 25

Figure 26

Distal Locking (long nails)

Priortolockingthedistalscrew(s),checkfemoral

lengthandrotationunderfluoroscopy.Distal

lockingoflongnailsshouldbeconducted

usingthestandardimageintensification

freehandtechnique.

Option 1–Usingtheshort4.3mmgraduated

drill(Cat.No.2112-01-406)andthe4.3mmdrill

measuringsleeve(Cat.No.2112-01-410),drill

untilthefarcortexiseitherreachedorpenetrated.

Verifythedrillbitpositionfluoroscopicallyprior

totakinganymeasurements.Readthecalibration

directlyoffofthe4.3mmgraduateddrillbyusing

thedrillmeasuringsleeve.Themeasurementshould

betakenfromtheendofthemeasuringsleeve,

closesttothepowersource(Figure25).

Option 2–Usingtheshort4.3mmgraduateddrill

(Cat.No.2112-01-406),drilluntilthefarcortexis

eitherreachedorpenetrated.Removethe4.3mm

graduateddrillandmeasureusingthedistalscrew

depthgauge(Cat.No.2112-01-404).Ensurethat

thesheathofthedistalscrewdepthgaugeisfully

seatedonthebone(Figure26).

Removethedrillbitandadvancethe5.0mmscrew

usingthesolidlokscrewdriveror3.5mmhexdriver

(Cat.No.2112-01-409).Repeattheabovestepsfor

additionalscrewplacement.

25

Figure 31

End Cap Placement

End Cap Placement (optional )

Unscrewthejigboltthatconnectstheinsertionjig

totheendofthenailusingthejigboltdriver

(Cat.No.2810-13-037or2810-13-006).Remove

theinsertionjigandusefluoroscopytodetermine

thelengthoftheendcapdesired,withagoalof

leavingtheproximalaspectoftheendcapflush

withthetipofthegreatertrochanter.

Attachtheendcaptothe5mmendcaphexdriver

(Cat.No.2112-01-600or2112-01-601)andinsert

intotheendofthenail.Tightentheendcapby

turningclockwiseuntiltheendcapfullyseats

againstthetopofthenail.IffixationoftheAR

screwisdesired,selecttheimpingingincapinstead

ofthestandardendcap(Figure31).

26

Implant Removal

Identifytheproximalendofthenailbyopeningthe

sameincisionusedforinsertionoftheimplantand

removetheendcap(ifpresent)withthe5mmend

caphexdriver(Cat.No.2112-01-600or

2112-01-601).

•Removethedistalscrewusingthe3.5mmhex

driver(Cat.No.2112-01-409)aftermakingan

incisionthroughthescarsite

•Loosenthesetscrewusingthe5mmsetscrew

hexdriver(Cat.No.2112-01-309)toallowthe

lagscrewtorotatecounterclockwise.

•Attachthelagscrewdriver(Cat.No.2112-01-

307)andcouplingrod(Cat.No.2112-01-306)to

thelateralendofthelagscrewandconfirmthat

itwillfreelyrotateinacounterclockwisedirection.

•Insertthecannulatedextractionbolt(Cat.No.

2112-01-666)intotheproximalendofthe

nail(Figure32).

•Attachtheextractionrod(Cat.No.1095)

totheextractionbolt.

•Removethelagscrewbyturning

counterclockwiseandthenremovethe

distalinterlockingscrews.

•Usetheslidinghammer(Cat.No.1796or1096)

orslottedmallet(Cat.No.2112-01-606)over

theextractionrodandbackslaptoremove

thenail(Figure33).

Note: It is recommended that the extraction

rod and bolt be attached to the nail prior

to removing the final screw to prevent

the nail from being forced down the

intramedullary canal.

Note: The conical extractor (Cat. No. 2112-01-

605) is designed to cross thread onto the nail,

and it is recommended that it is tightly secured

to the nail before the lag screw is removed

to prevent the nail from rotating in the

femoral canal.

Figure 32

Figure 33

Implant Removal

SlottedHammer SlidingHammer

27

Implant Diagrams

Distal Screw, 20-80 mmSterile:8145-50-0XX

•Diameter5.0mm•3.5mmHexDriverSocket

Anti-rotation Screw, 50-110 mmSterile:8145-01-XXX

•Diameter5.0mm•3.6mmHexDriverSocket•3mmInnerThreadforRemoval•SelfTappingThreads

Lag Screw, 70-130 mmSterile:8145-10-XXX

•Diameter10.5mm•ReverseButtressThread•6.5mmSquareDriverSocket•SelfTappingThreads

30 mm

25 mm

125˚ &

130˚12.76 mm

Diameter 9.0 mm Diameter 11.0 mm Diameter 13.0 mm Diameter 15.0 mm

1.8 M Radius of Curvature

6 mm Dynamization

Range

10° Proximal Anteversion

15.6 mm Proximal Diameter

3˚

4˚

28

Product Ordering InformationRights Lefts Rights Lefts

Long Nails, 9 MM, 125° Long Nails, 9 MM, 130°

8143-09-260 8144-09-260 125°9MMX260MM 8145-09-260 8146-09-260 130°9MMX260MM

8143-09-280 8144-09-280 125°9MMX280MM 8145-09-280 8146-09-280 130°9MMX280MM

8143-09-300 8144-09-300 125°9MMX300MM 8145-09-300 8146-09-300 130°9MMX300MM

8143-09-320 8144-09-320 125°9MMX320MM 8145-09-320 8146-09-320 130°9MMX320MM

8143-09-340 8144-09-340 125°9MMX340MM 8145-09-340 8146-09-340 130°9MMX340MM

8143-09-360 8144-09-360 125°9MMX360MM 8145-09-360 8146-09-360 130°9MMX360MM

8143-09-380 8144-09-380 125°9MMX380MM 8145-09-380 8146-09-380 130°9MMX380MM

8143-09-400 8144-09-400 125°9MMX400MM 8145-09-400 8146-09-400 130°9MMX400MM

8143-09-420 8144-09-420 125°9MMX420MM 8145-09-420 8146-09-420 130°9MMX420MM

8143-09-440 8144-09-440 125°9MMX440MM 8145-09-440 8146-09-440 130°9MMX440MM

8143-09-460 8144-09-460 125°9MMX460MM 8145-09-460 8146-09-460 130°9MMX460MM


8143-11-260 8144-11-260 125°11MMX260MM 8145-11-260 8146-11-260 130°11MMX260MM

8143-11-280 8144-11-280 125°11MMX280MM 8145-11-280 8146-11-280 130°11MMX280MM

8143-11-300 8144-11-300 125°11MMX300MM 8145-11-300 8146-11-300 130°11MMX300MM

8143-11-320 8144-11-320 125°11MMX320MM 8145-11-320 8146-11-320 130°11MMX320MM

8143-11-340 8144-11-340 125°11MMX340MM 8145-11-340 8146-11-340 130°11MMX340MM

8143-11-360 8144-11-360 125°11MMX360MM 8145-11-360 8146-11-360 130°11MMX360MM

8143-11-380 8144-11-380 125°11MMX380MM 8145-11-380 8146-11-380 130°11MMX380MM

8143-11-400 8144-11-400 125°11MMX400MM 8145-11-400 8146-11-400 130°11MMX400MM

8143-11-420 8144-11-420 125°11MMX420MM 8145-11-420 8146-11-420 130°11MMX420MM

8143-11-440 8144-11-440 125°11MMX440MM 8145-11-440 8146-11-440 130°11MMX440MM

8143-11-460 8144-11-460 125°11MMX460MM 8145-11-460 8146-11-460 130°11MMX460MM


8143-13-260 8144-13-260 125°13MMX260MM 8145-13-260 8146-13-260 130°13MMX260MM

8143-13-280 8144-13-280 125°13MMX280MM 8145-13-280 8146-13-280 130°13MMX280MM

8143-13-300 8144-13-300 125°13MMX300MM 8145-13-300 8146-13-300 130°13MMX300MM

8143-13-320 8144-13-320 125°13MMX320MM 8145-13-320 8146-13-320 130°13MMX320MM

8143-13-340 8144-13-340 125°13MMX340MM 8145-13-340 8146-13-340 130°13MMX340MM

8143-13-360 8144-13-360 125°13MMX360MM 8145-13-360 8146-13-360 130°13MMX360MM

8143-13-380 8144-13-380 125°13MMX380MM 8145-13-380 8146-13-380 130°13MMX380MM

8143-13-400 8144-13-400 125°13MMX400MM 8145-13-400 8146-13-400 130°13MMX400MM

8143-13-420 8144-13-420 125°13MMX420MM 8145-13-420 8146-13-420 130°13MMX420MM

8143-13-440 8144-13-440 125°13MMX440MM 8145-13-440 8146-13-440 130°13MMX440MM

8143-13-460 8144-13-460 125°13MMX460MM 8145-13-460 8146-13-460 130°13MMX460MM

Long Nails, 15 MM, 130°

8145-15-320 8146-15-320 130°15MMX320MM

8145-15-360 8146-15-360 130°15MMX360MM

8145-15-400 8146-15-400 130°15MMX400MM

8145-15-440 8146-15-440 30°15MMX440MM

29

short Nails, 125°

8143-09-180 125°9MMX180MM

8143-11-180 125°11MMX180MM

8143-13-180 125°13MMX180MM

short Nails, 130°

8145-09-180 130°9MMX180MM

8145-11-180 130°11MMX180MM

8145-13-180 130°13MMX180MM

Lag screws

8145-10-070 LAGSCREW10.5MMX70MM













Anti-Rotation screws

8145-01-050 A/RSCREW50MM

8145-01-055 A/RSCREW55MM

8145-01-060 A/RSCREW60MM

8145-01-065 A/RSCREW65MM

8145-01-070 A/RSCREW70MM

8145-01-075 A/RSCREW75MM

8145-01-080 A/RSCREW80MM

8145-01-085 A/RSCREW85MM

8145-01-090 A/RSCREW90MM

8145-01-095 A/RSCREW95MM

8145-01-100 A/RSCREW100MM

8145-01-105 A/RSCREW105MM

8145-01-110 A/RSCREW110MM

Distal screws

8145-50-020 CORTICALBONESCR5.0MMX20MM

























End Caps

8145-03-000 ENDCAPFLUSH

8145-03-005 ENDCAP5MM

8145-03-101 INCAPFLUSHIMPINGING

30

Product Ordering Information

Affixus Hip fracture Nail system2112-01-000 INSTRUMENTCASE22112-01-001 INSTRUMENTCASE12112-01-004 INSTRUMENTKITBASIC2112-01-005 INSTRUMENTKITFULL

1 2 3 4 5

6 8 9 10 117

* Products are disposable.

Reduction9030-03-004 THREADEDGUIDEPIN3.2MM*2810-01-080 BALLNOSEGUIDEWIRE80CM*2810-01-100 BALLNOSEGUIDEWIRE100CM*2810-01-001 PISTOLGUIDEWIREGRIPPER 62810-01-026 GUIDEWIREPUSHER 72810-01-007 LONGREDUCTIONTOOL 82142-02-012 BALLSPIKEPUSHER 92112-01-003 BONEHOOK 102141-19-000 FEMORALBONECLAMP 11

General2810-01-004 T-HANDLEHUDSON8261-66-000 RATCHETSCREWDRIVERHANDLESMALL

Entry2112-01-100 AWL 12112-01-102 ENTRYREAMERSOLIDSHAFT 22112-01-103 ENTRYREAMERFLEXIBLESHAFT 32112-01-104 ENTRYPORTAL 42810-13-004 ENTRYPORTALTROCHAR 5

31

12

13 14

15

16 17

18 19 20 21 22 23 24 25 26 27 28

Nail insertion2112-01-106 NAILDEPTHGAUGE 122112-01-200 INSERTIONJIG125° 132112-01-201 INSERTIONJIG130° 142112-01-202 INSERTIONJIGBOLT 152112-01-205 JIGKNOB2112-01-206 JIGKNOBRETAINER2810-13-037 FLEXIBLEJIGBOLTDRIVER8MM 162810-13-006 JIGBOLTDRIVER8MM2112-01-204 IMPACTIONTOOL 17

Lag screw Placement2112-01-300 LAGSCREWSHEATH 182112-01-301 LAGSCREWTROCHAR 192112-01-302 LAGSCREW3.2MMSLEEVE 202112-01-304 LAGSCREWDEPTHGAUGE 212112-01-303 LAGSCREWDRILL 222112-01-310 LAGSCREWTAP 232112-01-307 LAGSCREWDRIVER 242112-01-306 LAGSCREWCOUPLINGROD 252112-01-308 COMPRESSIONWHEEL 262112-01-309 5MMHEXDRIVER-SETSCREW 272112-01-312 GUIDEPINPOSITIONINGTOOL 28

32

Product Ordering Information

29

37 38 39 40 41 42 43 44 45 46 47

30 31 32 33 34 35 36

* Products are disposable.

AR screw Placement2112-01-501 A/RSCREWSHEATH 292112-01-502 A/RSCREWTROCHAR 302112-01-503 A/RSCREW3.2MMSLEEVE 312112-01-505 A/RSCREWDRILL* 322112-01-504 3.5MMHEXDRIVERLONG-AR/DISTALSCREW 332112-01-506 A/RSCREWREMOVALTOOL 34

Distal screw insertion 2112-01-401 DISTALSCREWSHEATH 372112-01-402 DISTALSCREWTROCHAR 382112-01-403 DISTALSCREWDRILLSLEEVE 392112-01-404 DISTALSCREWDEPTHGAUGE 402112-01-406 4.3MMDISTALGRADUATEDDRILLSHORT* 412112-01-405 4.3MMDISTALGRADUATEDDRILLLONG* 422112-01-410 4.3MMDRILLMEASURINGSLEEVE* 432112-01-409 3.5MMHEXDRIVERSHORT-DISTALSCREW 442810-01-020 SOLIDLOKSCREWDRIVERHANDLE 452810-01-021 SOLIDLOKDRIVERINNERSHAFT 462810-01-019 SOLIDLOKHEXTIP3.5MML* 47

End Cap Placement 2112-01-600 5MMHEXDRIVERENDCAP 352112-01-601 5MMHEXCANNDRIVERENDCAP2112-01-602 ENDCAPREMOVALTOOL 36

33

48 49

50

51

52

Extraction 2112-01-666 CANNULATEDEXTRACTIONBOLT 481095 EXTRACTIONROD 491796 SLIDINGHAMMERSMALL 501096 SLIDINGHAMMERLARGE2112-01-606 SLOTTEDMALLET 512112-01-605 CONICALEXTRACTOR 522810-01-027 3/4IN.HEXDRIVER 53

2810-04-100 10.0MMMODULARREAMERHEAD2810-04-105 10.5MMMODULARREAMERHEAD2810-04-110 11.0MMMODULARREAMERHEAD2810-04-115 11.5MMMODULARREAMERHEAD2810-04-120 12.0MMMODULARREAMERHEAD2810-04-125 12.5MMMODULARREAMERHEAD2810-04-130 13.0MMMODULARREAMERHEAD2810-04-135 13.5MMMODULARREAMERHEAD2810-04-140 14.0MMMODULARREAMERHEAD2810-04-145 14.5MMMODULARREAMERHEAD2810-04-150 15.0MMMODULARREAMERHEAD2810-04-155 15.5MMMODULARREAMERHEAD2810-04-160 16.0MMMODULARREAMERHEAD2810-04-165 16.5MMMODULARREAMERHEAD2810-04-170 17.0MMMODULARREAMERHEAD

flexible Reamers 2810-02-400 400MMNITINOLMODULARREAMERHUDSON2810-02-470 470MMNITINOLMODULARREAMERHUDSON2810-02-015 150MMREAMEREXTENSION2810-02-081 8MMMNBLCENDCUTREAMERHUDSON2810-02-091 9MMMNBLCENDCUTREAMERHUDSON2810-04-090 9.0MMMODULARREAMERHEAD2810-04-095 9.5MMMODULARREAMERHEAD

Printed in USA. ©2010 DePuy Orthopaedics, Inc. All rights reserved.

Screws, Plates, Intramedullary Nails, Compression Hip Screws, Pins and Wires

Important:

ThisEssentialProductInformationdoesnotincludealloftheinformationnecessaryforselectionanduseofadevice.Pleaseseefulllabelingforallnecessaryinformation.

Indications:

Theuseofmetallicsurgicalappliances(screws,plates,intramedullarynails,compressionhipscrews,pinsandwires)providestheorthopaedicsurgeonameansofbonefixationandhelpsgenerallyinthemanagementoffracturesandreconstructivesurgeries.Theseimplantsareintendedasaguidetonormalhealing,andareNOTintendedtoreplacenormalbodystructureorbeartheweightofthebodyinthepresenceofincompletebonehealing.Delayedunionsornonunionsinthepresenceofloadbearingorweightbearingmighteventuallycausetheimplanttobreakduetometalfatigue.Allmetalsurgicalimplantsaresubjectedtorepeatedstressinuse,whichcanresultinmetalfatigue.

Contraindications:

Screws,plates,intramedullarynails,compressionhipscrews,pinsandwiresarecontraindicatedin:activeinfection,conditionswhichtendtoretardhealingsuchasbloodsupplylimitations,previousinfections,insufficientquantityorqualityofbonetopermitstabilizationofthefracturecomplex,conditionsthatrestrictthepatient’sabilityorwillingnesstofollowpostoperativeinstructionsduringthehealingprocess,foreignbodysensitivity,andcaseswheretheimplant(s)wouldcrossopenepiphysealplatesinskeletallyimmaturepatients.

Additional Contraindication for Orthopaedic Screws and Plates only:

Caseswithmalignantprimaryormetastatictumorswhichprecludeadequatebonesupportorscrewfixations,unlesssupplementalfixationorstabilizationmethodsareutilized.

Additional Contraindication for Retrograde Femoral Nailing:

Ahistoryofsepticarthritisofthekneeandkneeextensioncontracturewithinabilitytoattainatleast45ºofflexion.

DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581-0988USATel: +1 (800) 366 8143Fax: +1 (574) 267 7196

DePuy International LtdSt Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0)113 387 7800Fax: +44 (0)113 387 7890

2.5M0810 0612-13-510

Additional Contraindications for Compression Hip Screws only:

Inadequate implant support due to the lack of medial buttress.

Warnings and Precautions:

Bonescrewsandpinsareintendedforpartialweightbearingandnon-weightbearingapplications.Thesecomponentscannotbeexpectedtowithstandtheunsupportedstressesoffullweightbearing.

Adverse Events:

Thefollowingarethemostfrequentadverseeventsafterfixationwithorthopaedicscrews,plates,intramedullarynails,compressionhipscrews,pinsandwires:loosening,bending,crackingorfractureofthecomponentsorlossoffixationinboneattributabletononunion,osteoporosis,markedlyunstablecomminutedfractures;lossofanatomicpositionwithnonunionormalunionwithrotationorangulation;infectionandallergiesandadversereactionstothedevicematerial.Surgeonsshouldtakecarewhentargetinganddrillingfortheproximalscrewsinanytibialnailwithobliqueproximalscrews.Careshouldbetakenasthedrillbitisadvancedtopenetratethefarcortex.Advancingthedrillbittoofarinthisareamaycauseinjurytothedeepperonealnerve.Fluoroscopyshouldbeusedtoverifycorrectpositioningofthedrillbit.

Additional Adverse Events for Compression Hip Screw only:

Screwcutoutofthefemoralhead(usuallyassociatedwithosteoporoticbone).

Medos International SARLChemin - Blanc 382400 Le Locle, Switzerland

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