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Surgical Protocol by E. Lyle Cain, M.D. and Jeffrey R. Dugas, M.D. of the American Sports Medicine Institute

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Surgical Protocol by E. Lyle Cain, M.D. andJeffrey R. Dugas, M.D.

of the American Sports Medicine Institute

Flexible obturator, drill and anchor work in conjunction with curved guide.

Features• Allowsanchorstobeeasilyplacedonthelower positions

(4:00 – 8:00 o’clock)forBankarttearsaroundtheglenoidwithoutcompromisingthesubscapularistendonoftherotatorcuff

• Anchorcanbeinsertedatthecorrectanatomicallocationtothebonewhentyingdownsofttissue

• Curvedinstrumentsidealforarthroscopiclabralrepairsintheshoulderandhip

• 2.9mmresorbableMicroMax™AnchorwithMaxBraid™Sutureonaflexibleshaft

The f rst deployable anchor to be inserted through a curved guide.

IndicationsShoulder Indications• Bankartrepair• SLAPlesionrepair• Acromioclavicular(AC)separation

• Rotatorcuffrepair• Capsulerepairorcapsulolabralreconstruction

• Bicepstenodesis• Deltoidrepair

Wrist Indications• Scapholunateligamentreconstruction

Elbow Indications• Tenniselbowrepair• Ulnarorradialcollateralligamentreconstruction

• Bicepstendonreattachment

•Medialandlateralrepairs

Knee Indications (Extra-capsular repair)•Medialcollateralligamentrepair

• Lateralcollateralligamentrepair

• Posteriorobliqueligamentrepair

• Jointcapsuleclosure• Iliotibialbandtenodesisreconstruction

• Patellarligament/tendonrepair

• Vastusmedialisobliquus(VMO)muscleadvancement

ThisbrochureispresentedtodemonstratethesurgicaltechniqueutilizedbyE.LyleCain,M.D.andJeffreyR.Dugas,M.D.BiometSportsMedicine,asthemanufacturerofthisdevice,doesnotpracticemedicineanddoesnotrecommendthisoranyothersurgicaltechniqueforuseonaspecificpatient.Thesurgeonwhoperformsanyprocedureisresponsiblefordeterminingandutilizingtheappropriatetechniquesforsuchprocedureforeachindividualpatient.BiometSportsMedicineisnotresponsibleforselectionoftheappropriatesurgicaltechniquetobeutilizedforanindividualpatient.

The f rst deployable anchor to be inserted through a curved guide.

Portal PlacementAccesslabralpathologytocarryoutarthroscopicshoulderstabilizationutilizingaflexible5mmAquaLoc®Cannula.Placementofthecannulashouldbejustsuperiortothesubscapularistendonusingananterior/inferiorportal(Figure1).

Prepare SurfaceTopromotefibroblastichealingtobone,ableedingbonesurfaceispreparedwiththeBiometSportsMedicinerasp/elevatorsystem(Figure2).

A15˚or30˚BiometSportsMedicinetissueelevatorsmayhelpfreesignificanttissuescarringoffthescapularneck.Ashavermayneedtobeintroducedtoremoveanyfibrousadhesions.

Figure 1 Figure 2

Surgical Technique—MicroMax™ FLEX Suture Anchor

Place Curved GuideThecurveddesignoftheMicroMax™guideallowseasyaccesstothelower5o’clockpositionforanatomicalattachmentofthelabraltissue.Thecurvedguideispassedthroughtheflexibleanterior/inferior5or7mmAquaLoc®Cannulaatthelowerpositionoftheglenoid.PositionMicroMax™curvedguidetodesiredlocationonglenoidbone(Figure3).

Drill Pilot Hole with the Flexible DrillInserttheMicroMax™FLEXdrillbitintopowerdrilltoproximallaser-etchlinetoensureappropriatedepthasthecollarofthedrillcontactsthatbackoftheguide(Figure4).InserttheMicroMax™drillintothedrillguide(Figure5)Advancedrilluntilcontactismadewithcurvedguide(Figure6).

Figure 3

Figure 5

Figure 6

Figure 4

Insert AnchorRemovethedrill.Note: Caution must be taken to maintain precise guide position over the pilot hole during removal. Whilemaintainingthecurvedguidepositionfirmlyagainstthebone,insertthe2.9mmMicroMax™FLEXSutureAnchorthroughguideandintothepilothole.Firmlypushthehandletofullyseatthe2.9mmMicroMax™FLEXimplant(Figure7).Alignthelaseretchmarkstoensureanchorisinsertedtoappropriatedepth(Figures8aand8b).

Figure 8 Figure 8a

Figure 8b

Surgical Technique—MicroMax™ FLEX Suture Anchor

Deploy AnchorOnceanchorhasbeenfullyseatedintoglenoidbone,pushthegreensafetybuttonintothehandle(Figure9).Whilemaintainingpressure,deployimplantusingforefingerstofirmlypullbacktheblueslide(Figure10)

Thetriggerpullstheinnerpinintothebodyandengagestheflanges.Theanchorhandlecanthenberemovedfromtheguide.Removecurveddrillguidefromthejoint(Figure11).

Pullonthe#2MaxBraid™Sutureattachedtoanchortoensureanchorisseatedinbone(Figure12).

Figure 10

Figure 11Figure 9

Figure 12

Retrieve SutureTheVampire™SutureGrasperisusedtotransferasinglesuturelimbtoanterior/superiorportal.Thetipoftheinstrumentcanbeusedtoseparatethesuturestrandstoretrievedesiredlimbofsuture.

TheSpeedPass™SutureLariat25˚isinsertedintotheanterior/inferiorcannulaandpassedthroughlabraltissueinferiortoanchorposition.OncethetipoftheSpeedPass™Lariatpenetratesthetissue,theNitinolwirecanbemanuallyadvancedintothejoint

(Figure13).Throughtheanterior/superiorportaltheVampire™SutureGrasperisusedtoretrievetheNitinolwireloop(Figure14),andtheSpeedPass™Lariatinserterisremoved.

Outsidetheanterior/superiorportal,fivecentimetersofsutureofthesuturelimbispassedthroughtheNitinolwireloop,andthewireextendingoutanterior/inferiorcannulasispulledoutthecannula(Figures15aand15b)whichshuttlesthesuturethroughthelabraltissueandouttheinferiorcannula(Figure16).

Figure 13

Figure 14

Figure 15a

Figure 15b

Surgical Technique—MicroMax™ FLEX Suture Anchor

Desiredarthroscopicknotsarethentiedwithanopenorclosedknotpusher(Figure17).

TheSlottedMaxCutter™canbeusedtocutMaxBraid™Suture.

SLAP RepairSLAPrepairmaybeperformedinasimilarmanner.TheMicroMax™FLEXSutureAnchorcanbeinsertedpercutaneouslywithatrocartoeliminatecannulaplacementthroughtherotatorcuff.Suturesaretransferredtotheanterior/superiorcannula(Figure18).

Figure 16

Figure 17

Figure 18

Features• Push-ininsertionwithmechanicaldeployment

• Easydeploymentsystem

• Sutureslideseasilythroughanchor

• LoadedwithMaxBraid™Suture

• Smallimplantsizeallowsformultipleimplantplacement

• 2.9and3.9mmsizes

• Fishmouthguideallowsaccurateanchorplacement

Portal PlacementAccesslabralpathologytocarryoutarthroscopicshoulderstabilizationutilizingaflexible5mmAquaLoc®Cannula.Placementofthecannulashouldbejustsuperiortothesubscapularistendonusingananterior/inferiorportal(Figure1).

Figure 1

Figure 2

Surgical Technique —MicroMax™ Suture Anchor

Prepare SurfaceTopromotefibroblastichealingtobone,ableedingbonesurfaceispreparedwiththeBiometSportsMedicinerasp/elevatorsystem(Figure2).

A15˚or30˚BiometSportsMedicinetissueelevatorsmayhelpfreesignificanttissuescarringoffthescapularneck.Ashavermayneedtobeintroducedtoremoveanyfibrousadhesions.

Surgical Technique—MicroMax™ Suture Anchor

Insert MicroMax™Drill GuideLoadMicroMax™drillbitintopowerdrilltoproximallaser-etchline(Figure3).PositionMicroMax™fishmouthguidetodesiredlocationonglenoidbone.Asharptrocarorbluntobturatorcanbeusedtoinserttheguideintothegleno-humeraljoint.InserttheMicroMax™drillintothedrillguide(Figure4).Advancedrilluntilcontactismadewithguide(Figure5aand5b).

Figure 4

Figure 3

Figure 5b

Figure 5a

Figure 7b

Figure 6

Figure 7a

Insert MicroMax™Suture AnchorRemovethedrill.Extremecautionmustbetakentomaintainpreciseguidepositionoverthepilotholeduringremoval.Whilemaintainingdrillguideposition,inserttheMicroMax™Anchorthroughthedrillguideandintothepilothole(Figure6).Firmlypushthehandletofullyseattheimplant.Alignthelaseretchmarkstoensureanchorisinsertedtoappropriatedepth(Figure7aand7b).

Deploy AnchorPushthegreensafetybuttonintothehandle(Figure8).Whilemaintainingpressure,deploytheimplantbyusingforefingerstofirmlypullbacktheslide(similartousingasyringe)(Figure9).

Figure 8

Surgical Technique—MicroMax™ Suture Anchor

Figure 9

Figure 10

Figure 11

Thetriggerpullstheinnerpinintothebodyandengagestheflanges(Figure10).Theanchorhandlecanthenberemovedfromtheguide(Figure11).Removethedrillguidefromthejoint.

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 Medicine, Inc. 01-50-1072P.O.Box587 Date:01/0756EastBellDriveWarsaw,Indiana46581USA

Biomet Sports Medicine™ Resorbable Soft Tissue Anchoring Devices

ATTENTION OPERATING SURGEON

DESCRIPTIONTheBiometSportsMedicine™SoftTissueAnchoringDevicesareresorbablerepairdevicesusedtoattachsofttissuetobone.Thedevicesareavailablewithorwithoutasuture.Thedevicesareimplantedintoapredrilledboneholeandaremadeofaresorbablecopolymer,apolyesterderivativeoflacticacidandglycolicacid.Polylactic/polyglycolicacidcopolymerdegradesandresorbsin vivo byhydrolysistolacticandglycolicacids,whicharethenmetabolizedbythebody.

MATERIALSPoly-L-LacticAcid/PolyglycolicAcidUltra-HighMolecularWeightPolyethylene(UHMWPE)PolyesterPolypropylene

INDICATIONS 1.LactoScrew®L-15ScrewAnchor(85%PLLA/15%PGA)and

theALLthread™LactoSorb®SutureAnchor: Shoulder Bankartrepair SLAPlesionrepair Acromio-clavicularseparation Rotatorcuffrepair Capsulerepairorcapsulolabralreconstruction Bicepstenodesis Deltoidrepair Wrist/Hand Scapholunateligamentreconstruction Ulnar/radialcollateralligamentreconstruction Ankle/Foot Lateralstabilization Medialstabilization Achillestendonrepair/reconstruction Halluxvalgusreconstruction Mid-andforefootreconstruction Elbow Tenniselbowrepair Ulnarorradialcollateralligamentreconstruction Bicepstendonreconstruction Knee Medialcollateralligamentrepair Lateralcollateralligamentrepair Posteriorobliqueligamentrepair Jointcapsuleclosure Iiotibialbandtenodesis Patellarligament/tendonrepair 2.LactoSorb®L-15ScrewandWasher(85%PLLA/15%PGA),

MicroMax™SutureAnchor,andLactoSorb®L-15Hitch™SutureAnchor:

Shoulder BankartRepair SLAPLesionRepair Acromio-clavicalurSeparationRepair RotatorCuffRepair CapsuleRepairandCapsulolabralReconstruction BicepsTenodesis DeltoidRepair Wrist Scapholunateligamentreconstruction Elbow TennisElbowRepair BicepsTendonReattachment MedialandLateralRepairs UlnarorRadialCollateralLigamentReconstruction Knee Extra-CapsularRepair MedialCollateralLigamentRepair LateralCollateralLigamentRepair PosteriorObliqueLigamentRepair JointCapsuleClosure IliotibialBandTenodesisReconstruction PatellarLigament/TendonRepair VastusMedialisObliquus(VMO)MuscleAdvancement

LactoSorb®L-15ScrewandWasherandMicroMax™SutureAnchorarepreloadedwithsutureforuseatthediscretionofthephysician.

CONTRAINDICATIONS 1.Activeinfection. 2.Patientswithmentalorneurologicconditionswhoare

unwillingorincapableoffollowingpostoperativecareinstructions.

3.Patientconditionsincluding:bloodsupplylimitations,insufficientquantityorqualityofbone,orlatentinfections.

4.Pathologicsofttissueconditions,whichwouldpreventsecurefixation.

WARNINGSBiometSportsMedicine™internalfixationdevicesprovidethesurgeonwithameanstoaidinthemanagementofsofttissuetobonereattachmentprocedures.Whilethesedevicesaregenerallysuccessfulinattainingthesegoals,theycannotbeexpectedtoreplacenormalhealthysofttissue,orwithstandthestressplaceduponthedevicebyfullorpartialweightbearingorloadbearing,particularlyinthepresenceofincompletehealing.Therefore,itisimportantthatimmobilization(useofexternalsupport,sling,etc.)ofthetreatmentsitebemaintaineduntilhealinghasoccurred.Surgicalimplantsaresubjecttorepeatedstressesinuse,whichcanresultinfractureordamagetotheimplant.Factorssuchasthepatient’sactivitylevelandadherencetoweightbearingorloadbearinginstructionshaveaneffectontheservicelifeoftheimplant.Thesurgeonmustbethoroughlyknowledgeablenotonlyinthemedicalandsurgicalaspectsoftheimplant,butalsomustbeawareofthemechanicalandpolymericaspectsofthesurgicalimplants.

1.Correctselectionoftheimplantisextremelyimportant.Thepotentialforsuccessinsofttissuetobonefixationisincreasedbytheselectionofthepropertypeofimplant.Whileproperselectioncanhelpminimizerisks,thedeviceisnotdesignedtowithstandtheunsupportedstressoffullweightbearing,loadbearingorexcessiveactivity.

2.Theimplantscanloosenorbedamagedwhensubjectedtoincreasedloadingassociatedwithinadequatehealing.Ifhealingisdelayed,ordoesnotoccur,theimplantortheproceduremayfail.Loadsproducedbyweightbearingandactivitylevelsmaydictatethelongevityoftheimplant.

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

4.Careistobetakentoassureadequatesofttissuefixationatthetimeofsurgery.Failuretoachieveadequatefixationorimproperpositioningorplacementofthedevicecancontributetoasubsequentundesirableresult.

5.Theuseofappropriateimmobilizationandpostoperativemanagementisindicatedaspartofthetreatmentuntilhealinghasoccurred.

6.Correcthandlingofimplantsisextremelyimportant.Donotmodifyimplants.Donotnotchorbendimplants.Notchesorscratchesputintheimplantduringthecourseofsurgerymaycontributetobreakage.Intraoperativefractureofdevicescanoccurifexcessiveforce(torque)isappliedwhileseating.

7.Donotuseexcessiveforcewheninsertingsutureanchors.Excessiveforce(e.g.longhardhammerblows)maycausefractureorbendingofthedevice.Priortoinsertionoftheimplant,predrill,awl,ortap.

8.DONOTUSEifthereislossofsterilityofthedevice. 9.DiscardandDONOTUSEopenedordamageddevices,

anduseonlydevicesthatarepackagedinunopenedorundamagedcontainers.

10.Ensurecontactoftissuetobonewhenimplanting.DONOTOVERTIGHTENthescrew.Structuraldamagetothetissueandimplantmayoccurifthescrewisovertightened.

11.Adequatelyinstructthepatient.Postoperativecareisimportant.Thepatient’sabilityandwillingnesstofollowinstructionsisoneofthemostimportantaspectsofsuccessfulsofttissuemanagement.Patientsaffectedwithsenility,mentalillness,alcoholism,anddrugabusemaybeatahigherriskofdeviceorprocedurefailure.These

patientsmayignoreinstructionsandactivityrestrictions.Thepatientistobeinstructedintheuseofexternalsupportsthatareintendedtoimmobilizetherepairsiteandlimitweightbearingorloadbearing.Thepatientistobemadefullyawareandwarnedthatthedevicedoesnotreplacenormalhealthytissue,andthatthedevicecanbreak,bendorbedamagedasaresultofstress,activity,loadbearing,orweightbearing.Thepatientistobemadeawareandwarnedofgeneralsurgicalrisks,possibleadverseeffects,andtofollowtheinstructionsofthetreatingphysician.Thepatientistobeadvisedoftheneedforregularpostoperativefollow-upexaminationaslongasthedeviceremainsimplanted.

12.MicroMax™SutureAnchor—Lossofbonefixationmayoccurifflangedwingsarenotproperlydeployed.

PRECAUTIONSInstrumentsareavailabletoaidintheaccurateimplantationofinternalfixationdevices.Intraoperativefractureorbreakingofinstrumentshasbeenreported.Surgicalinstrumentsaresubjecttowearwithnormalusage.Instrumentsthathaveexperiencedextensiveuseorexcessiveforcearesusceptibletofracture.Surgicalinstrumentsshouldonlybeusedfortheirintendedpurpose.BiometSportsMedicinerecommendsthatallinstrumentsberegularlyinspectedforwearanddisfigurement.

IfdevicecontainsMaxBraid™suture,refertomanufacturerpackageinsertforfurtherinformation.

POSSIBLE ADVERSE EFFECTS 1. Infectioncanleadtofailureoftheprocedure. 2.Neurovascularinjuriescanoccurduetosurgicaltrauma. 3.Bending,fracture,loosening,rubbing,andmigrationofthe

implantmayoccurasaresultofexcessiveactivity,trauma,orloadbearing.

4. Implantationofforeignmaterialscanresultinaninflammatoryresponseorallergicreaction.

5. Inadequatehealing. 6.Pain,discomfort,orabnormalsensationduetothepresence

ofthedevice. 7.Necrosisoftheboneortissue.

STERILITYBiometSportsMedicine™resorbableimplantsaresterilizedbyexposuretoEthyleneOxide(ETO)Gas.Donotresterilize.Donotusepastexpirationdate.

STORE AT OR BELOW ROOM TEMPERATURE. DO NOT EXPOSE PRODUCT TO TEMPERATURES GREATER THAN 120°F OR 49°C.

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

CommentsregardingthisdevicecanbedirectedtoAttn:RegulatoryDept,Biomet,P.O.Box587,Warsaw,IN46581USA,FAX:574-372-1683

AuthorizedRepresentative: BiometU.K.,Ltd. WatertonIndustrialEstates Bridgend,SouthWales CF313XAU.K.

СЄ0086

Package Inserts

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.

Distributed by:Biomet Sports Medicine, Inc. 01-50-113456EastBellDrive Date:02/08P.O.Box587Warsaw,Indiana46581USA

MaxBraid™

POLYETHYLENE SUTURENon-absorbable Surgical SutureU.S.P. except for oversized diameter.

Sterile: Contentssterileunlesspackagehasbeenopenedordamaged.SingleUseOnly,DoNotResterilize.

DESCRIPTIONMaxBraid™PolyethyleneSurgicalSutureisanonabsorbable,sterilesurgicalsuturecomposedofultrahighmolecularweightpolyethylene.MaxBraid™PolyethyleneSutureisprovidedundyed(white),asaco-braidofundyedpolyethyleneandbluemonofilamentpolypropyleneorasaco-braidofundyedpolyethyleneandblackmonofilamentnylon.MaxBraid™suturesareU.S.P.exceptfordiameterinthefollowingsizes:

MaxBraid™ sutures exceed USP specifcations for diameter.

SutureSize

USPAve.Diameter

Specification(mm)<861>

MaximumOversizeAverage

Diameter(mm)

MaximumOversizeAverageDiameter

fromUSP(mm)

5–0 0.200–0.149 0.150 0.0014–0 0.150–0.199 0.224 0.0253–0 0.200–0.249 0.318 0.0692–0 0.300–0.339 0.363 0.0240 0.350–0.399 0.406 0.0071 0.400–0.499 0.541 0.0422 0.500–0.599 0.630 0.0313 0.600–0.699 0.754 0.0554 0.600–0.699 0.754 0.0555 0.700–0.799 0.861 0.062

INDICATIONSMaxBraid™PolyethyleneNonabsorbableSurgicalSuturesareindicatedforuseinapproximationand/orligationofsofttissues,includinguseofallografttissuefororthopedicsurgeries.

ACTIONSMaxBraid™PolyethyleneSurgicalSutureelicitsaminimalacuteinflammatoryreactionintissues,whichisfollowedbygradualencapsulationofthesuturebyfibrousconnectivetissue.

WARNINGSDo not resterilize. Do not use if package is opened or damaged. Discard open, unused sutures.

UsersshouldbefamiliarwithsurgicalproceduresandtechniquesinvolvingnonabsorbablesuturesbeforeemployingPolyethyleneSurgicalSutureforwoundclosure,astheriskofwounddehiscencemayvarywiththesiteofapplicationandthesuturematerialused.

Aswithanyforeignbody,prolongedcontactofthisoranyothersuturewithsaltsolutions,suchasthosefoundinurinaryorbiliarytracts,mayresultincalculusformation. Acceptablesurgicalpracticemustbefollowedwithrespecttodrainageandclosureofinfectedorcontaminatedwounds.

PRECAUTIONSInhandlingthisoranyothersuturematerial,careshouldbetakentoavoiddamagefromhandling.Avoidcrushingorcrimpingdamageduetoapplicationofsurgicalinstrumentssuchasforcepsorneedleholders.

Adequateknotsecurityrequirestheacceptedsurgicaltechniqueofflat,squareties,withadditionalthrowsaswarrantedbysurgicalcircumstanceandtheexperienceofthesurgeon.

Usersshouldexercisecautionwhenhandlingsurgicalneedlestoavoidinadvertentneedlesticks.Discardusedneedlesin“sharps”containers.

Thisdeviceshouldbehandledanddisposedofinaccordancewithallapplicableregulationsincluding,withoutlimitation,thosepertainingtohumanhealthandsafetyandtheenvironment.

ADVERSE REACTIONSAdverseeffectsassociatedwiththeuseofthisdeviceinclude:wounddehiscence,calculiformationinurinaryandbiliarytractswhenprolongedcontactwithsaltsolutionssuchasurineandbileoccurs,infectedwounds,minimalacuteinflammatorytissuereaction,andtransitorylocalirritation.

HOW SUPPLIEDMaxBraid™PolyethyleneSurgicalSutureisavailableinUSPsizes5-0through5(metricsizes1through7).MaxBraid™PolyethyleneSutureisprovidedsterile.MaxBraid™PolyethyleneSutureisprovidedundyed(white),asaco-braidofundyedpolyethyleneandbluemonofilamentpolypropylene,orasaco-braidofundyedpolyethyleneandblackmonofilamentnylon.Thesutureisprovidedinavarietyoflengths,withandwithoutneedles,withorwithoutpledgets,andmaybesuppliedinavarietyofcutlengthsoronligatingreels.Finishedsuturemaybepackagedincartonsassinglepacks,multipacks,orprocedurepacks.

STERILITYMaxBraid™PolyethyleneNonabsorbableSurgicalSuturesaresterilizedbyexposuretoEthyleneOxide(ETO)Gas.Donotresterilize.Donotusepastexpirationdate.

MaxBraid™isatrademarkofBiometSportsMedicine,Inc.

Caution:Federallaw(USA)restrictsthisdevicetosale,distributionorusebyorontheorderofaphysician.

CommentsregardingthisdevicecanbedirectedtoAttn:RegulatoryDept.,BiometInc.,P.O.Box587,Warsaw,IN46581USA,Fax:574-372-3968

Biomet®andallothertrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiaries.

Manufacturer: TeleflexMedical 600AirportRoad FallRiver,MA02720USA 508-677-6600

Telephone 800-367-7874(USAonly) +1-508-677-6600

SutureCEmarkedbyTeleflex

BiometSportsMedicine 214650014861E.AirportDr. Date:09/08Ontario,CA91761

WARNINGS AND PRECAUTIONS FOR USEOFFLEXIBLE

MICROMAX™DISPOSABLECURVEDGUIDESYSTEM

DESCRIPTIONFlexibleMicroMax™CurvedGuideSystemsaretobeusedforpreparationofbonetoallowinsertionofMicroMax™Sutureanchorsinproceduresforwhichtheanchorisindicated.Thesystemcontainsaflexibledrillthatpassesthroughacurvedguide.

MATERIALS: StainlessSteelABSPlastic

Instruction for Use, Care, Handling:

GeneralUse:Usethedrillsonlyfortheirintendedpurpose,topreparebonetoallowinsertionofMicroMax™Sutureanchorsinproceduresforwhichtheanchorisindicated.Refertoproductliteratureforthespecificsizeandordernumberforeachimplantsystem.

1.LoadtheMicroMax™drillbitintothepowerdrillsotheedgeofthetri-shankdriveportionisflushwiththetipofthedrillchuck.Tightenthedrillchuck.

2. Introducetheguideintothejointwiththeaidoftheprovidedobturator.Removetheobturatoronceinsidethejoint.

3.Positiontheguidetipsecurelyonthebonyanatomyatthedesiredsutureanchorlocation.Orienttheguidehandletoachievethedesiredholetrajectory.

4.CarefullyinserttheMicroMax™drillbitintothedrillguideandslowlyadvancethedrilluntilcontactwiththebonyanatomy.

5.Begindrillingandslowlyadvancethedrilluntilthedrillchuckcontactsthebackoftheguidehandle.

6.Continuetodrillslowlyclockwiseasthedrillisgentlyremovedfromtheguide.Extremecautionmustbetakentomaintainpreciseguidepositionoverthepilotholeduringdrillremoval.

7.Whilemaintainingguidepositionandtrajectory,theanchormaybeinsertedthroughtheguideintothepilotholeandfullyseatedaccordingtotheMicroMax™Sutureanchorinstructionsforuse.

Themaximumrecommendeddrillspeedis900RPMinordertoavoidfailuressuchasbreakageofthedrill.

WARNINGS: Intraoperative separation (fracture) of the cutting head from the flexible shaft can occur. Fractured cutting heads may lodge in bone causing added surgery time and surgical complications.

PRECAUTIONS:

1.FlexibledrillsaretobeusedwiththecurvedguidewhichwillbepackagedwiththedrillintheFlexibleMicroMax™CurvedGuideSystem.Takecautioninhandling.Theuseofthecurvedguideprovidessupportfortheflexibledrill,shieldingthedrillfromexcessivebending.Failuretousethecurvedguidemaycausefractureofthedeviceandsurgicalcomplicationsassociatedwithremovalofafracturedcuttinghead.

2.TheCurvedGuideshouldbeheldfirmlyinplaceagainstboneforthedurationofthedrillingcycle.Anytranslationoftheguideorchangeintheangleoftheguideafterthedrilltiphasenteredthebonecanresultinfractureofthedrill.

3. Instrumentsthathaveexperiencedextensiveuseorexcessiveforcearesusceptibletofracture.Donotapplyexcessiveforcestotheflexibleportionofthedrillpriortoinsertionintotheguideoruseexcessiveforceduringdrilling.

4.Extensiveuseofflexibledrillswillresultinnormaldullingofthecuttingheads.Biometrecommendsthatallflexibledrillsbeexaminedfordamageandsharpnesspriortothedrillingofeachholeduringthecase.Drillsthataredullorperforminginadequatelyduringthecaseshouldbedisposedof.

5. Incasesrequiringhigherquantitiesofanchors(greaterthan3)oraboveaveragebonehardness,usemultipledrillswithinthecaseandlimitthenumberofholescreatedwitheachdrill.

6.TheFlexibleMicroMax™CurvedGuideSystemispackagedsterile.Donotattempttoresterilizeanycomponentofthesystem.Donotusethesysteminmorethanonecase.Resterilizationprocesseswillcompromisethemechanicalstrengthoftheinstruments.Whileaninstrumentmayappearundamaged,previousstressmayhavecreatedimperfectionsthatwouldreducetheservicelifeoftheinstrument.

7.Donotuseinstrumentsthathavebeen,evenmomentarily,placedinadifferentpatient. 8.Donotuseifthereisalossofsterilityoftheinstrument. 9.DiscardandDONOTUSEopenedordamageddevices,anduseonlydevicesthatarepackaged

inunopenedorundamagedcontainers.10.Correcthandlingofinstrumentsisextremelyimportant.Donotmodifyinstruments.Donot

notchorbendinstruments.Examinetheflutesofthedrillheadperiodicallyfordamageorwear.Notches,scratchesorotherdamageand/orwearintheinstrumentoccurringduringsurgerymaycontributetobreakage.

11.Donotreshapeorbendthedrillshaftinanyway.Iftheshaftshouldbecomebentfromitsoriginalshape,donotuse,asthiswillaffecttheperformanceofthedrill.Bentdrillshaftsshouldbedisposedof.

STERILITYTheFlexibleMicroMax™CurvedGuideSystemaresuppliedsterile,andaresterilizedbyaminimumdoseof25kGyofgammaradiation.Donotresterilize.Donotusepastexpirationdate.

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

CommentsregardingthisdevicecanbedirectedtotheCustomerServiceDept.Ontario,CA,telephone#1-800-535-8692.

Biomet®andallothertrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiaries.

AuthorizedRepresentative: Biomet,U.K.,Ltd. WatertonIndustrialEstate Bridgend,SouthWales

CF313XA,U.K.

СЄ0086

Ordering Information

MicroMax™ Disposable Kit (Straight)904995

MicroMax™ Drill Bits905465 2.9mmLong905475 3.9mmLong

MicroMax™ Suture Anchors

905453905473

2.9mm3.9mm

MicroMax™ Drill Guides905461R 2.9mmOffsetGuideLong905471 3.9mmOffsetGuideLong

MicroMax™ Obturators905460 2.9mmBluntLong905462 2.9mmTrocarLong905470 3.9mmBluntLong905472 3.9mmTrocarLong

MicroMax™ FLEX Disposable Kit (Curved)904998

MicroMax™ FLEX Suture Anchors

905456 2.9mm

MicroMax™ Suture Anchors

MicroMax™ FLEX Suture Anchors

P.O.Box587,Warsaw,IN46581-0587•800.348.9500ext.1501©2009SportsMedicine•www.biometsportsmedicine.com

FormNo.BSM0165.0•REV021509

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ThismaterialisintendedforthesoleuseandbenefitoftheBiometsalesforceandphysicians.Itisnottoberedistributed,duplicatedordisclosedwithouttheexpresswrittenconsentofBiomet.

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

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