Medial Patellofemoral Ligament (MPFL) Reconstruction

Surgical Protocol by Ronald Navarro, M.D.

with

Features• Auniqueweaveinwhichasinglestrandofbraidedpolyethyleneiswoventhroughitselftwiceinoppositedirections.

• ThisconstructallowsBiometSportsMedicinetoproduceinnovativeproductsthatcanvaryinlengthandcompression/tensionaddressingtheindividualneedsofeachpatient.

• ProductsutilizingZipLoop™Technologyareresistanttoslippagewithouttyingknots1.

Benefits• Maximizessofttissuegraft-to-tunnelinterface

• Oneimplantforvaryingtunnellengths—eliminatestheneedformultiplesizes

• Virtuallynoslippageaftercyclicloading1

• Simplesurgicaltechniquerequiresminimalinstrumentation

• Designedtocapturecorticalbone

ThisbrochureispresentedtodemonstratethesurgicaltechniqueandpostoperativeprotocolutilizedbyRonaldNavarro,M.D..BiometSportsMedicine,asthemanufacturerofthisdevice,doesnotpracticemedicineanddoesnotrecommendthisoranyothersurgicaltechniqueforuseonaspecificpatient.Thesurgeonwhoperformsanyprocedureisresponsiblefordeterminingandutilizingtheappropriatetechniquesforsuchprocedureforeachindividualpatient.BiometSportsMedicineisnotresponsibleforselectionoftheappropriatesurgicaltech-niquetobeutilizedforanindividualpatient.

Surgical Technique

Indications for Surgery• Severeinstabilityofthepatella

• Subluxationofthepatella

ContraindicationsIfpatellarinstabilityisonlyduetothesedifferentialdiagnoses• Trochlearhypoplasia• Generalizedligamentouslaxity• Patellaalta• Patellarfacetdysplasia

General PositioningThepatientisbroughttotheoperatingtheaterandplacedinthesupinepositiononasplitlegtableifpossible.Afteradequateanesthesiaisobtainedthepatient'sinvolvedlowerextremityhasathighhightourniquetplacedbutitisnotinflated.Aftersterileprepanddrape,1%lidocaineandepinephrineisinjectedinferomediallyandinferolaterally(ifdiagnosticarthroscopyistobeperformed)aswellasmediallyatthefemoralepicondyle,mediallyattheinsertionoftheMPFLandinandaroundthehamstringsinsertionsofthetibia.

Diagnostic Arthroscopy/Possible TrochleoplastyIfdeemedappropriateduetothepossibilityofunderlyingintra-articularpathologyortheneedfortrochleoplastyorlateralrelease,adiagnosticarthroscopyisperformed.Incisionsaremadeinferomediallyandinferolaterallyinthetypicalportallocationsforkneearthroscopy.Thearthroscopeisintroduced.Evidenceofchondralchangeisassessedonthepatella.Thiscanthenbedebridedusingashaver.Moreelaboratecartilagerestorationmethodsaredescribedseparatelyintheliterature.Allotherintra-articularmeniscalandchondralpathologycanbeassessedandtreatedasdictatedbypriorinformedconsent.

IfonpreoperativeassessmentincludingCTscan,asupra-trochlearbumpisseenthismaydeviatethepatellaoutofthecentraltrackinthetrochlea.Theremaybeabenefittotakedownthisbumpanddeepenthetrochlea.Anarthroscopicburrorbonecuttingshavercanbeusedtoperformthistask.Anyanteriorfemoralcorticaloutcroppingcanbetakendownwhilebeingcarefulnottocreateastressriserinthisregion.Ifrelativetrochlearhypoplasiaispresentwithflatteningofthenormaltrochlearconcavity,typicalcaptureofthepatellainearlykneeflexioncannotoccur.Thetrochlearcentralgrooveisdeepenedinthissettingwiththeuseofabonecuttingshaverdirectlyonthemostproximaltrochleararticularcartilage.Thegoalistodeepenonlythemostproximaltrochleaandnotremovetheentirearticularsurface.

Anarthroscopiclateralreleaseisperformedifnegativepatellartiltexists(wherethelateralpatellacannotbetiltedmediallyinthecoronalplanetoapositionwherethepatellacouldbeparalleltothefloorifthepatientisinthesupinepositionandthetoesareintheuppointingor12o’clockposition).Thearthroscopyisthenterminatedandthekneedecompressedtobeginthemedialpatellarfemoralligamentreconstruction.

Figure 1

Figure 2

Graft Preparation Adoubledgraftof5.5–7.0mmdoubleddiameterisrequired.Ifanallograftischosenasthegraftchoice,usuallyasofttissuegraftischosen.Ifahamstringsautograftischosen,anincisionismadeattheanteriormedialaspectofthetibia.Thesartorialfasciaisvisualized.Itisthencutinlinewiththeunderlyingtendons.Thesemitendinosusisremovedandtaggedusingaclosedendtendonstripperafteritstibialinsertionandattachmentstothemedialgastrocnemiusarereleased.Thesartorialfasciaisclosedwitharunningstitch.ThesemitendinosusorsofttissueallograftistakentothebacktableanddoubledoverapassingstichifusingtheComposiTCP™InterferenceScrew(wheretheloopedendisplaced)ortheloopedendofaToggleLoc™FixationDevicewithZipLoop™Technology(Figure1).Theresultantdoubledgraftisrunthroughatendonsizertoobtainitslargestdiameter.Thediameterisnotedforlaterdrilling.

Thefreeendsofthegraftarethentaggedwithprovisionaltensionstitchesandthegraftisplacedonagraftboardintensiononthebacktable.Itiswrappedinamoistlapsponge,awaitingitsuseinthereconstructiveeffort.

Femoral PreparationIfasplitlegtableisused,theuninvolvedextremityisabductedsomedialworkcanensue.A1cmincisionismadeoverthemedialepicondyleprominenceandtheincisionistakendowntobonethroughmultiplemediallayers.Themedialepicondyleispalpatedandapositionjustsuperiorandslightlyposteriortothetipoftheepicondylareminenceischosenforplacementofaguidepin(Figure2).Thepinisdrilledtothelateralsurfaceofthefemur,beingcarefulnottodeviatetooanteriorlyintothearticularsurfaceofthetrochlea(Figure3).

Figure 3

Surgical Technique (continued)

Figure 5Figure 4

IsometryAsuturecanbeplacedaroundthepinandpassedbetweenLayer2andLayer3ofthemedialanatomyofthekneetoasmallincisiononthesuperomedialpatellaforisometrytesting.Itisimportanttoavoidexcessivemedialpatellarfacettensioninflexion(femoralpointtooproximal)andmedialpatellardisplacementinextension(femoralpointtoodistal).

Femoral DrillingThepininthefemurisover-drilledwithanacornreamerbitofdiametercorrespondingtothediameterofthegraftpreparedandsizedearliertoadistanceof30–35mm(Figure4).Theremainingtunnellengthisover-drilledwiththe4.5mmdrillbittoaccommodatethepassageoftheToggleLoc™Device(Figure5)orleftaloneifutilizingaComposiTCP™Screw.Flouroscopicguidancecanhelpsimplifythisstep.

Femoral Graft DeliveryThegraftisdeliveredintotheclosedendfemoraltunnelusingtheBeathpin.TheToggleLoc™Deviceispassedandthenflippedonthelateralfemoralcortex(Figure6a&b).ThezipstrandoftheToggleLoc™deviceisthenpulledtointroducetheloopedendofthegraftintothetunnel.Thegraftcanbemarkedwithamarkingpenat25,30and35mmawayfromthebuttendtohelptracktheamountofgraftthathasbeenintroducedintothefemoraltunnel(Figure7).Itisrecommendedthatlessthanthefulllengthofgraftthatcanbeintroducedonthefemoralsideinitiallybeintroduced(Figure8a).IfusingtheComposiTCP™InterferenceScrew,thegraftisintroducedto30mmandtheComposiTCP™InterferenceScrewofappropriatesizeandlengthisplacedinlinewiththegraftwhileplacingtensiononeithersideofthegraft(Figure8b).

Figure 6a

Figure 6b

Figure 7

Figure 8a

Figure 8b

Surgical Technique (continued)

Patellar PreparationAnincisionismadejustmedialtothepatella.AsthetypicalpatellarinsertionsiteoftheMPFLis6mmdistaltothesuperiorpoleofthepatella,thefocusissuperomediallyonthepatella(Figure9).AnatomicalLayer2ofthemedialkneeisincisedandLayer3issparedunlessopenpatellarcartilagerestorationproceduresarecontemplated.Thissamesuperomedialpatellapositionischosenforplacementofaguidepin.Thepinisdrilledtothelateralsurfaceofthepatella,beingcarefulnottodeviatetooanteriorlyintothenonarticularsurfaceofthepatellaorposteriorlyintothepatellararticulatingfacets(Figure10).

Patellar DrillingThepininthepatellaisoverdrilledwithanacornreamerofthediametercorrespondingtothediameterofthegraftpreparedandsizedearliertoadistanceof15–25mm(Figure11).Theremainingtunnellengthisoverdrilledwiththe4.5mmdrillbittoaccommodatethepassageoftheToggleLoc™Device(Figure12).Flouroscopicguidancecanhelpsimplifythisstep.

Figure 9 Figure 11

Figure 10

Figure 12

Graft Limb CuttingThegraftispassedfromthemedialfemoralincisiontotheanteriormedialpatellarincisionunderneathLayer2(Figure13).Thegraftlimbsareremeasuredfromthepointofinsertionintothemedialpatellartunnelandtrialedwithvaryingamountsof“MPFL”length.Lateralpatellarlaxityischeckedwitheachofthelengthstofindalengthwherethepatellacanglideonequadrantlaterallyinfullextension.ThisisthepointwherethecheckreineffectoftheMPFLreconstructionwouldblockanyfurtherabnormallateraldisplacement.

Newsuturesareplacedinthetwofreelimbsforadistancethatmatchesthelengthoftheacornreamedpatellartunnelandtheremainingexcessgraftandinitialtensionstitchesarecutaway(Figure14).

Figure 13

Figure 14

Figure 15

Figure 16a

Patellar Graft DeliveryThetwostitchesfromthefreelimbsaretiedtoasecondToggleLoc™DeviceviatheZipLoop™sutureloopedends(Figure15).TheToggleLoc™Deviceispassedandthenflippedonthelateralpatellarcortex(Figure16a&b).ThesuturepullingstrandsoftheToggleLoc™Devicearethenpulledupontointroducethefreelimbsofgraftintothetunnel.Thegraftcanbemarkedwithamarkingpenat15,20and25mmawayfromtheendsofthegrafttohelptracktheamountofgraftthathasbeenintroducedintothepatellartunnel(Figure17).

Surgical Technique (continued)

Figure 16b

Figure 17

25mm

20mm

15mm

Customizable Final Tensioning of PatellaAtthispoint,thefinaltensioningofthepatellacantakeplace.BecauseoftheZipLoop™Technology,tensioningcantakeplaceonboththepatellasideandthefemoralsidetoensurethepatellahasnormallateralglideinfullextension,trochlearengagementofthepatellain30to45degreesofflexionandtheabilitytoachievefullflexionwithoutgraftstretch(Figure18).

Figure 18

Closure and RehabilitationTheincisionsarethenirrigatedfreelyandclosedinlayers.Steriledressingsareapplied.Ahingedkneebraceisplaced.Thepatientcanweightbearinfullextensionimmediatelywithcrutchaide.Rangeofmotionisinitiatedfrom0to30degreesofrangeimmediately(non-weightbearing).Progressiveincreaseinflexionshouldoccuroverthenext4-6weekstoachievefullflexionandweaningofthecrutchesandbrace.Progressivestrengtheningofthequadricepsandhamstringswithincreaseinfunctionalmovementshelpsfacilitaterecovery.Patientscantypicallyreturntosportsactivitiesin4-6months.

Package Insert

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet Sports Medicine at the contact information provided herein.

Biomet Sports Medicine56EastBellDrive

P.O.Box587Warsaw,Indiana46581USA

01-50-1186 Date:03/09

Biomet Sports Medicine ToggleLoc™ System

ATTENTION OPERATING SURGEON

DESCRIPTIONTheToggleLoc™Systemisanon-resorbablesystemintendedtoaid inarthroscopicandorthopedic reconstructiveproceduresrequiring soft tissue fixation, due to injury or degenerativedisease.MATERIALSTitaniumAlloyUltra-HighMolecularWeightPolyethylene(UHMWPE)PolypropyleneNylonPolyesterStainlessSteelINDICATIONS FOR USETheToggleLoc™Systemdevicesareintendedforsofttissuetobonefixationforthefollowingindications:ShoulderBankartlesionrepairSLAPlesionrepairsAcromio-clavicularrepairCapsularshift/capsulolabralreconstructionDeltoidrepairRotatorcufftearrepairBicepsTenodesisFoot and AnkleMedial/lateralrepairandreconstructionMid-andforefootrepairHalluxvalgusreconstructionMetatarsalligament/tendonrepairorreconstructionAchillestendonrepairAnkle Syndesmosis fixation (Syndesmosis disruptions) and asan adjunct in connectionwith trauma hardware forWeber BandCanklefractures(only for ToggleLoc™ with Tophat)ElbowUlnarorradialcollateralligamentreconstructionLateralepicondylitisrepairBicepstendonreattachmentKnee ACL/PCLrepair/reconstructionACL/PCLpatellarbone-tendon-bonegraftsDouble-TunnelACLreconstructionExtracapsularrepair:MCL,LCL,andposteriorobliqueligamentIlliotibialbandtenodesisPatellartendonrepairVMOadvancementJointcapsuleclosureHand and WristCollateralligamentrepairScapholunateligamentreconstructionTendontransfersinphalanxVolarplatereconstructionHipAcetabularlabralrepairCONTRAINDICATIONS 1. Infection. 2.Patientconditionsincludingbloodsupplylimitations,and

insufficientquantityorqualityofboneorsofttissue. 3.Patientswithmentalorneurologicconditionswhoare

unwillingorincapableoffollowingpostoperativecareinstructions.

4.Foreignbodysensitivity.Wherematerialsensitivityissuspected,testingistobecompletedpriortoimplantationofthedevice.

WARNINGSThe ToggleLoc™ System devices provide the surgeon witha means to aid in the management of soft tissue to bonereattachment procedures. While these devices are generallysuccessful in attaining these goals, they cannot be expectedtoreplacenormalhealthyboneorwithstandthestressplaced

upon the device by full or partial weight bearing or loadbearing, particularly in the presence of nonunion, delayedunion, or incomplete healing. Therefore, it is important thatimmobilization (useofexternal support,walkingaids,braces,etc.) of the treatment site be maintained until healing hasoccurred. Surgical implants are subject to repeated stressesinuse,whichcanresult infractureordamagetothe implant.Factors such as the patient’s weight, activity level, andadherencetoweightbearingorloadbearinginstructionshaveaneffectontheservice lifeofthe implant.Thesurgeonmustbe thoroughly knowledgeable not only in the medical andsurgicalaspectsoftheimplant,butalsomustbeawareofthemechanicalandmetallurgicalaspectsofthesurgicalimplants.Patientselectionfactorstobeconsideredinclude:1)needforsoft tissue to bone fixation, 2) ability and willingness of thepatienttofollowpostoperativecareinstructionsuntilhealingiscomplete,and3)agoodnutritionalstateofthepatient

1.Correctselectionoftheimplantisextremelyimportant.Thepotentialforsuccessinsofttissuetobonefixationisincreasedbytheselectionofthepropertypeofimplant.Whileproperselectioncanhelpminimizerisks,neitherthedevicenorgrafts,whenused,aredesignedtowithstandtheunsupportedstressoffullweightbearing,loadbearingorexcessiveactivity.

2.Theimplantscanloosenorbedamagedandthegraftcanfailwhensubjectedtoincreasedloadingassociatedwithnonunionordelayedunion.Ifhealingisdelayed,ordoesnotoccur,theimplantortheproceduremayfail.Loadsproducedbyweightbearingandactivitylevelsmaydictatethelongevityoftheimplant.

3. Inadequatefixationatthetimeofsurgerycanincreasetheriskoflooseningandmigrationofthedeviceortissuesupportedbythedevice.Sufficientbonequantityandqualityareimportanttoadequatefixationandsuccessoftheprocedure.Bonequalitymustbeassessedatthetimeofsurgery.Adequatefixationindiseasedbonemaybemoredifficult.Patientswithpoorqualitybone,suchasosteoporoticbone,areatgreaterriskofdevicelooseningandprocedurefailure.

4. Implantmaterialsaresubjecttocorrosion.Implantingmetalsandalloyssubjectsthemtoconstantchangingenvironmentsofsalts,acids,andalkalisthatcancausecor-rosion.Puttingdissimilarmetalsandalloysincontactwitheachothercanacceleratethecorrosionprocessthatmayenhancefractureofimplants.Everyeffortshouldbemadetousecompatiblemetalsandalloyswhenmarryingthemtoacommongoal,i.e.,screwsandplates.

5.Careistobetakentoensureadequatesofttissuefixationatthetimeofsurgery.Failuretoachieveadequatefixationorimproperpositioningorplacementofthedevicecancontributetoasubsequentundesirableresult.

6.Theuseofappropriateimmobilizationandpostoperativemanagementisindicatedaspartofthetreatmentuntilhealinghasoccurred.

7.Correcthandlingofimplantsisextremelyimportant.Donotmodifyimplants.Donotnotchorbendimplants.Notchesorscratchesputintheimplantduringthecourseofsurgerymaycontributetobreakage.

8.DONOTUSEifthereisalossofsterilityofthedevice.9. DiscardandDONOTUSEopenedordamageddevices,

anduseonlydevicesthatarepackageinunopenedorundamagedcontainers.

10.Adequatelyinstructthepatient.Postoperativecareisimportant.Thepatient’sabilityandwillingnesstofollowinstructionsisoneofthemostimportantaspectsofsuccessfulfracturemanagement.Patientseffectedwithsenility,mentalillness,alcoholism,anddrugabusemaybeatahigherriskofdeviceorprocedurefailure.Thesepa-tientsmayignoreinstructionsandactivityrestrictions.Thepatientistobeinstructedintheuseofexternalsupports,walkingaids,andbracesthatareintendedtoimmobilizethefracturesiteandlimitweightbearingorloadbearing.Thepatientistobemadefullyawareandwarnedthatthedevicedoesnotreplacenormalhealthybone,andthatthedevicecanbreak,bendorbedamagedasaresultofstress,activity,loadbearing,orweightbearing.Thepatientistobemadeawareandwarnedofgeneralsurgicalrisks,pos-sibleadverseeffects,andtofollowtheinstructionsofthetreatingphysician.Thepatientistobeadvisedoftheneedforregularpostoperativefollow-upexaminationsaslongasthedeviceremainsimplanted.

PRECAUTIONSDo not reuse implants. While an implant may appearundamaged, previous stressmay have created imperfectionsthatwouldreducetheservicelifeoftheimplant.Donottreatwith implants thathavebeen, evenmomentarily,placed inadifferentpatient.Instruments are available to aid in the accurate implantationofinternalfixationdevices.Intraoperativefractureorbreakingof instruments has been reported. Surgical instruments aresubject towearwithnormalusage. Instruments,whichhaveexperienced extensive use or excessive force, are susceptibletofracture.Surgicalinstrumentsshouldonlybeusedfortheirintended purpose. Biomet Sports Medicine recommendsthat all instruments be regularly inspected for wear anddisfigurement.If device contains MaxBraid™ suture, refer to manufacturerpackageinsertforfurtherinformation.POSSIBLE ADVERSE EFFECTS

1.Nonunionordelayedunion,whichmayleadtobreakageoftheimplant.

2.Bendingorfractureoftheimplant. 3.Looseningormigrationoftheimplant. 4.Metalsensitivityorallergicreactiontoaforeignbody. 5.Pain,discomfort,orabnormalsensationduetothepres-

enceofthedevice. 6.Nervedamageduetosurgicaltrauma. 7.Necrosisofboneortissue. 8. Inadequatehealing. 9. Intraoperativeorpostoperativebonefractureand/or

postoperativepain.STERILITYThe ToggleLoc™ System devices are supplied sterile and aresterilized by exposure to Ethylene Oxide Gas (ETO) if devicecontainsMaxBraid™PEsuture. Donotresterilize. Donotuseanycomponentfromanopenedordamagedpackage.Donotusepastexpirationdate.Caution: Federal law (USA) restricts this device to sale,distribution,orusebyorontheorderofaphysician.CommentsregardingtheuseofthisdevicecanbedirectedtoAttn: RegulatoryAffairs,Biomet, Inc.,P.O.Box587,WarsawIN46581USA,Fax:574-372-3968.All trademarks herein are the property of Biomet, Inc. or itssubsidiariesunlessotherwiseindicated.AuthorizedRepresentative: BiometU.K.,Ltd. WatertonIndustrialEstate Bridgend,SouthWales CF313XA,U.K.

Manufacturer

DateofManufacture

DoNotReuse

ConsultAccompanyingDocuments

SterilizedusingEthyleneOxide

SterilizedusingIrradiation

Sterile

SterilizedusingAsepticTechnique

SterilizedusingSteamorDryHeat

ExpiryDate

WEEEDevice

CatalogueNumber

LotNumber

Flammable

Resorbable Interference ScrewUser undertaking:The user acknowledges having read these instructions, and undertakes to abide by them. Materials:DUOSORB™: 30% β-TriCalciumPhosphate / 70% Poly D Lactic Acid composite.Indications:The ComposiTCP™ 30 Interference Screw is designed for the interference fixation of bone-patellar tendon bone grafts in anterior cruciate ligament construction. The screws are cannulated and are available in different sizes (see commercial documentation). They have a specific head, which allows for a more even distribution of the torsional stresses. To achieve the optimal result, the ComposiTCP™ 30 Interference Screw should be implanted using a dedicated screwdriver contained in the instrumentation set.Contra-indications:Insufficient or poor-quality bone stock (including tumors and severe osteoporosis) is likely to affect screw purchase. Acute infection. Allergy to implant material. Conditions likely to limit the patient’s ability and/or willingness to restrict activities and/or to adhere to instructions during the healing and rehabilitation period.Adverse side effects:To date, no adverse effects have been observed and reported. Surgical precautions:The use of the ComposiTCP™ 30 Interference Screw requires sound knowledge of the anatomy and biomechanics of the knee joint, and of locomotor apparatus reconstruction surgery. Surgeons wishing to use the device must have been appropriately trained. The patient must be informed of the need for temporary restriction of activities and of the precautions to be taken following the insertion of the screw.Recommendations for use: 1. The ComposiTCP™ 30 Interference Screws must be used only for

ligament reconstruction. 2. Until graft healing is complete, fixation by means of this device

should be considered to be temporary, and the construct must not be subjected to excessive loading or other stress. Early stress on the screw or premature resumption of activity may lead to backing-out, bending, breakage or displacement of the screw. For this reason, appropriate immobilization, followed by supervised mobilization, will be required for a period of 4 to 6 weeks after surgery, or until there is clinical evidence of graft healing.

3. The ComposiTCP™ 30 Interference Screws must be completely

buried below the joint surface. 4. The ComposiTCP™ 30 Interference Screws must be screwed in

thanks to a specific screwdriver. No other screwdriver, however similar in appearance, must be used, since doing so may lead to screw breakage.

5.The diameter of the drill hole in the bone must be chosen as a func-tion of the diameter of the intented screw. Thus, an 8-mm ∅ screw requires a 9-mm ∅ drill hole ; a 9-mm ∅ screw, a 10-mm ∅ drill hole ; a 10-mm ∅ screw, an 11-mm ∅ drill hole ; and an 11-mm ∅ screw, a 12-mm ∅ drill hole.

6. Guide wire must not be twisted or bent prior to screw insertion, since doing so may impede screw insertion or result in screw breakage.

7. The ComposiTCP™ 30 Interference Screws must not be cut or altered under any circumstances.

8. Screwdriver must not be subjected to bending stress.Recommendations for devices supplied sterile:The ComposiTCP™ 30 Interference Screws have been Gamma-sterilized (dose 25 kGy). Prior to use of the device, the “sterile until” date on the packaging should be checked. SBM accepts no responsibility or liability for the use of products that are past their expiry date. The packaging should be checked for defects prior to use of the device. If inspection shows the packaging to be damaged, the product must be assumed to be non-sterile. The ComposiTCP™ 30 Interference Screws must not be re-sterilized. Any screws that have been removed from their packaging and remained unused must be discarded. Packaging:ComposiTCP™ 30 Interference Screws are supplied individually packaged in double peel-open packs. Prior to the use of the device, the integrity of the packaging must be checked. All the information required by law is given on the box or the label attached to the packaging.Storage conditions: ComposiTCP™ Interference Screws are to be stored at ambient temperature (15-30°C / 60-85°F), and normal relative humidity (50-80%). Storage conditions must be such as not to compromise the integrity of the packaging.Instrument:Screwdriver for ComposiTCP™ Interference Screws ø 7,8-mm is Ref. 905271, 905273 or LIG9008046.Screwdriver for ComposiTCP™ Interference Screws ø 9,10,11-mm is Ref. 905272, 905274 or LIG9009017.Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments should only be used for their intended purpose. It is recommended that all instruments be regularly inspected for wear and disfigurement.

Guarantee:The manufacturer’s guarantee does not apply unless the device is usedunderthenormalconditionsspecifiedintheseinstructions.

Reporting of adverse events:Anypersonhandlingthedevice(inacommercialorahealth-carecapacity)that has found the service provided by SBM and/or the quality, labeling,reliability,safety,efficacyand/ortheperformanceofSBMproductswantinginanywayshouldnotifytheSBMrepresentativeordistributor.

TherepresentativeordistributorshouldpassthecomplaintontotheSBMQualityManagerasquicklyaspossible,usinganadverseeventreportform.Theminimuminformationtobeprovidedonthisformshouldbe:productdescription,cataloguenumber,batchnumber,thenatureofthecomplaintoradetaileddescriptionoftheadverseeventanditsconsequencesforthepatientand/ortheuser.Anyevidencethatwouldfurthertheinvestigation(theimplantconcerned,X-rays,etc…)shouldbesentwiththeform.Ifpoorfunctionordeteriorationofan implant,orany fault in the instructions forusehaveledtoapatient’soranenduser’shealthbeingdamaged,thiseventshouldbereportedimmediatelybyphoneorfax.

Disposal:Thedeviceshouldbedisposedofobservingtheprecautionsthatapplytooperatingroomwaste.

Distributor:Biomet,SportsMedicine, Inc.,56EastBellDrive,POBox587,Warsaw,IN46581USA.

Manufactured By:S.B.M.,ZIduMonge–65100LOURDESFrance

Tel :+33(0)562422101/Fax :+33(0)562422100-www.s-b-m.fr

Caution: Federal Law (USA) restricts this device to sale, distribution, or use by or on the order of a physician.

Date of modification: January 2008

Date of CE mark: February 2009

0459

Use by

See instructions for use

Do not re-use

Sterilized using radiation

Date of manfacture

We cannot be held liable for any incident resulting from failure to comply with the principles described in these instructions.

The information contained in these package inserts was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet Sports Medicine at the contact information provided herein.

Package Insert

Resorbable Interference ScrewUser undertaking:The user acknowledges having read these instructions, andundertakestoabidebythem.

Materials:DUOSORB™:60%β-TriCalciumPhosphate /40%PolyDLacticAcidcomposite.

Indications:The ComposiTCP™ Interference Screw is exclusively used forthe fixation, by interference, of a transplant made out of pureligament, taken out for instance from the hamstring tendon,when reconstructing the anterior cruciate ligament. The screwsare cannulated and are available in different sizes, 7 thru 11-mm. They have a specific head, which allows for a more evendistributionofthetorsionalstresses.Toachievetheoptimalresult,theComposiTCP™InterferenceScrewshouldbeimplantedusingadedicatedscrewdrivercontainedintheinstrumentationset.

Contraindications:Insufficientorpoor-qualitybonestock(includingtumorsandsevereosteoporosis) is likely to affect screw purchase. Acute infection.Allergy to implantmaterial. Conditions likely to limit thepatient’sability and/orwillingness to restrict activities and/or to adhere toinstructionsduringthehealingandrehabilitationperiod.

Adverse side effects:Todate,noadverseeffectshavebeenobservedandreported.

Surgical precautions:The use of the ComposiTCP™ Interference Screw requires soundknowledgeoftheanatomyandbiomechanicsofthekneejoint,andof locomotor apparatus reconstruction surgery. Surgeonswishingtousethedevicemusthavebeenappropriatelytrained.Thepatientmustbeinformedoftheneedfortemporaryrestrictionofactivitiesandof theprecautions tobe taken following the insertionof thescrew.

Recommendations for use:

1.TheComposiTCP™InterferenceScrewmustbeusedonlyforliga-mentreconstruction.

2.Untilgrafthealingiscomplete,fixationbymeansofthisdeviceshouldbeconsideredtobetemporary,andtheconstructmustnotbesubjectedtoexcessiveloadingorotherstress.Earlystressonthescreworprematureresumptionofactivitymayleadtobacking-out,bending,breakageordisplacementofthescrew.Forthisreason,appropriateimmobilization,followedby

supervisedmobilization,willberequiredforaperiodof4to6weeksaftersurgery,oruntilthereisclinicalevidenceofgrafthealing.

3.TheComposiTCP™InterferenceScrewmustbecompletelyburiedbelowthejointsurface.

4.TheComposiTCP™InterferenceScrewmustbescrewedinthankstoaspecificscrewdriver.Nootherscrewdriver,howeversimilarinappearance,mustbeused,sincedoingsomayleadtoscrewbreakage.

5.Drillingdiameterofthebonetunnelmustbe,attheminimum,equaltothatofthescrew.

6.Guidewiremustnotbetwistedorbentpriortoscrewinsertion,sincedoingsomayimpedescrewinsertionorresultinscrewbreakage.

7.TheComposiTCP™InterferenceScrewmustnotbecutoralteredunderanycircumstances.

8.Screwdrivermustnotbesubjectedtobendingstress.Recommendationsfordevicessuppliedsterile:

TheComposiTCP™ Interference Screwhas beenGamma sterilized(dose25kGy).Priortouseofthedevice,the“sterileuntil”dateonthepackagingshouldbechecked.SBMacceptsnoresponsibilityorliabilityfortheuseofproductsthatarepasttheirexpirydate.Thepackagingshouldbecheckedfordefectspriortouseofthedevice.Ifinspectionshowsthepackagingtobedamaged,theproductmustbeassumedtobenon-sterile.TheComposiTCP™InterferenceScrewmustnotberesterilized.Anyscrewsthathavebeenremovedfromtheirpackagingandremainedunusedmustbediscarded.

Packaging:ComposiTCP™ Interference Screws are supplied individuallypackagedindoublepeel-openpacks.Priortotheuseofthedevice,theintegrityofthepackagingmustbechecked.Alltheinformationrequired by law is given on the box or the label attached to thepackaging.

Storage conditions:ComposiTCP™ Interference Screws are to be stored at ambienttemperature(15-30°C/60-85°F),andnormalrelativehumidity(50-80%).Storageconditionsmustbesuchasnot tocompromise theintegrityofthepackaging.

Instrument:ScrewdriverforComposiTCP™InterferenceScrewsø7,8-mmisRef.905271,905273orLIG9008046.

ScrewdriverforComposiTCP™InterferenceScrewsø9,10,11-mmisRef.905272,905274orLIG9009017.

Surgical instruments are subject to wear with normal usage.Instruments, which have experienced extensive use or excessive

force,aresusceptibletofracture.Surgical instrumentsshouldonlybe used for their intended purpose. It is recommended that allinstrumentsberegularlyinspectedforwearanddisfigurement.

Guarantee:Themanufacturer’sguaranteedoesnotapplyunless thedevice isusedunderthenormalconditionsspecifiedintheseinstructions.

Reporting of adverse events:Anypersonhandling thedevice (in a commercial or a healthcarecapacity) that has found the service providedby SBM and/or thequality,labeling,reliability,safety,efficacyand/ortheperformanceof SBM products wanting in any way should notify the SBMrepresentativeordistributor.

The representativeordistributor shouldpass thecomplainton totheSBMQualityManagerasquicklyaspossible,usinganadverseevent report form. The minimum information to be provided onthisformshouldbe:productdescription,cataloguenumber,batchnumber, the nature of the complaint or a detailed descriptionof theadverseevent and its consequences for thepatient and/orthe user. Any evidence that would further the investigation (theimplant concerned, Xrays, etc…)should be sent with the form.Ifpoor functionordeteriorationofan implant,orany fault in theinstructions forusehave led toapatient’soranenduser’shealthbeing damaged, this event should be reported immediately byphoneorfax.

Disposal:Thedevice shouldbedisposedofobserving theprecautions thatapplytooperatingroomwaste.

Manufactured For Distributor: Biomet, SportsMedicine, Inc., 56EastBellDrive,POBox587,Warsaw,IN46581USA.

Manufactured By:S.B.M.,ZIduMonge–65100LOURDESFrance–Tel:+33(0)562422101/Fax:+33(0)562422100–Website:www.s-b-m.fr.

Caution :FederalLaw(USA)restrictsthisdevicetosale,distribution,orusebyorontheorderofaphysician.

Date of modification: September 2008.

See instructions for use

Do not re-use

Sterilized using radiation

Wecannotbeheld liable forany incident resulting fromfailuretocomplywiththeprinciplesdescribedintheseinstructions.

The information contained in these package inserts was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet Sports Medicine at the contact information provided herein.

Ordering Information

ToggleLoc™ Disposable Kit909846 Includes: 2.4mmx13"DrillPointK-Wire 2.4mmx16"GraftPassingPin ToggleLoc™4.5mmDrillBit 2.4mmx10"DrillPointK-Wire 3.2mmDrillBit ACLBonePlug MarkingPen 6"Ruler

ToggleLoc™ Fixation Devicewith ZipLoop™ Technology 50"

904755

ToggleLoc™ Fixation Device

ComposiTCP™ Modular Driver905273 7–8mm905274 9–10mm

Universal Ratchet Driver900733 RatchetHandle

Modular Taps905277 7–8mm905278 9–11mm

ComposiTCP™ Interference ScrewComposiTCP™ Interference Screw

60% ß-TCP—Round Head

905256905257905258

9x25mm9x30mm9x35mm

ComposiTCP™ Interference Screw 60% ß-TCP—Fully Threaded

905261905262905263905264

10x30mm10x35mm11x30mm11x35mm

Modular Dilators905045 7–8mm905046 9–10mm

Nitinol Wires906849 1.1mmx14"906852 1.1mmx9"906856 0.9mmx14"

Instrument Case900300

ZipLoop™ Puller904776

Super MaxCutter™ Suture Cutter900342

ComposiTCP™ 30 Interference Screw—Round Head

905210905211905213905214905216905217905218

7x20mm7x25mm8x25mm8x30mm9x25mm9x30mm9x35mm

1.DataonfileatBiometSportsMedicine.Benchtestresultsarenotnecessarilyindicativeofclinicalperformance.

P.O.Box587,Warsaw,IN46581-0587•800.348.9500ext.1501©2010SportsMedicine•www.biometsportsmedicine.com

FormNo.BSM0224.0•REV022810

www.biometsportsmedicine.com

AlltrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiariesunlessotherwiseindicated.

ThismaterialisintendedforthesoleuseandbenefitoftheBiometsalesforceandphysicians.Itisnottoberedistributed,duplicatedordisclosedwithouttheexpresswrittenconsentofBiomet.

Forproductinformation,includingindications,contraindications,warnings,precautionsandpotentialadverseeffects,seethepackageinsertandBiomet’swebsite.

One Surgeon. One Patient.SM

1.WarrenLF,MarshallJL;“Thesupportingstructuresandlayersonthemedialsideoftheknee:ananatomicalanalysis.”The Journal of Bone and Joint Surgery,Vol.61Issue15662,1979.

2. DavisandFithian;“TechniquesofMedialRetinacRepairandReconstruction,”CORR,402September,pp38–52,2002.

3. ColvinAC,WestRV;“PatellarInstability”The Journal of Bone and Joint Surgery,”Vol.90:2751–2762,2008.

4. RedziniakDE,et al.;“PatellarInstability”The Journal of Bone and Joint Surgery,”Vol.91:2264–2275,2009.