surgical protocol by e. lyle cain, m.d. and jeffrey r ... · surgical protocol by e. lyle cain,...
TRANSCRIPT
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.
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.
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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.
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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
www.biometsportsmedicine.com
AlltrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiariesunlessotherwiseindicated.
ThismaterialisintendedforthesoleuseandbenefitoftheBiometsalesforceandphysicians.Itisnottoberedistributed,duplicatedordisclosedwithouttheexpresswrittenconsentofBiomet.
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One Surgeon. One Patient.