BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 3170037 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-02894
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION ON (B)(4) 2013. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE RETURNED STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING (PART#03.010.150, LOT#5770315) WAS RECEIVED FOR EVALUATION. THE RETURNED STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING WAS MANUFACTURED IN APRIL 2008 AND IS OVER 5 YEARS OLD. THE STARDRIVE TIPS ARE WORN AND TWISTED (APPROXIMATELY 25 DEGREES IN THE DIRECTION OF SCREW INSERTION). THE SCREWDRIVER SHAFT COMPONENT (PART#03.010.150.1, LOT#5513548) WAS MANUFACTURED FROM CUSTOM 465PH MATERIAL WHICH IS A TYPICAL MATERIAL SYNTHES USES FOR SCREWDRIVER SHAFTS. THE SHAFT IS ALSO HEAT TREATED TO INCREASE STRENGTH. THE 465PH MATERIAL USED FOR THE SCREWDRIVER SHAFT IS A MATERIAL CONDITION THAT ENCOURAGES THE DRIVER TO BEND INSTEAD OF BREAK. THE SAFER OPTION FOR THE PATIENTS IS FOR THE DRIVER TO FAIL IN BENDING, RATHER THAN BREAKING AND POTENTIALLY LEAVING SCREWDRIVER MATERIAL IN THE PATIENT. DESIGN VERIFICATION INDICATED THAT TIP DESIGN WAS SUFFICIENT TO WITHSTAND MAXIMUM REASONABLE HUMAN GRIP OVERLOAD CONDITION WHEN HELD IN LINE WITH SCREW AXIS. MISALIGNMENT BETWEEN SCREW AND SCREWDRIVER AXIS HAS BEEN SHOWN TO INCREASE SCREWDRIVER TIP WEAR. THE SCREWDRIVER DESIGN IS ADEQUATE FOR INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS (PART#03.010.024, LOT#019116) WAS RECEIVED FOR EVALUATION. THE RETURNED HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS WAS MANUFACTURED IN MARCH 2009 AND IS OVER 4 YEARS OLD. THE GROOVES IN THE RACK COMPONENT (PART#03.010.024.6) ARE WORN SEVERELY IN THE MIDDLE, PREVENTING CONSISTENT AND SECURE LOCKING/INTERFACING WITH THE EDGE OF THE LOCK COMPONENT. THE RACK COMPONENT IS MANUFACTURED FROM 17-4PH MATERIAL WHICH IS A TYPICAL MATERIAL USED TO MAKE DEVICE WHICH WILL BE SUSPECTED TO CONTINUOUS WEAR. THE RACK COMPONENT IS ALSO HEAT TREATED TO INCREASE STRENGTH. THE MATING LOCK COMPONENT (PART#03.010.024.4) IS ALSO MANUFACTURED FROM 17-4PH MATERIAL AND HEAT TREATED. THE VA-LCP PROXIMAL TIBIAL PLATE RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION. THE RETURNED STANDARD INSERTION HANDLE (PART#03.010.045, LOT#3104483) WAS RECEIVED FOR EVALUATION. THE RETURNED STANDARD INSERTION HANDLE WAS MANUFACTURED IN APRIL 2009 AND IS OVER 4 YEARS OLD. TWO DEEP BURRS EXIST ON THE DISTAL MOST GROOVES OF THE RETURNED INSERTION HANDLE WHICH WERE CAUSED WHEN THE SURGEON OVER TIGHTENED THE DRIVING CAP WITH THE WRENCH PER THE COMPLAINT DESCRIPTION. THE INSERTION HANDLE WAS MANUFACTURED FROM 17-4PH MATERIAL WHICH IS A TYPICAL MATERIAL SYNTHES USES TO MAKE INSERTION HANDLES. THE DEVICE IS ALSO HEAT TREATED TO INCREASE STRENGTH. THE DAMAGE ON THE RETURNED INSERTION HANDLE WAS CAUSED BY THE SURGEON OVER TIGHTENING THE DRIVING CAP WITH THE WRENCH, PER THE COMPLAINT DESCRIPTION. THE VA-LCP PROXIMAL TIBIAL PLATE RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION. THE RETURNED AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX (PART#03.010.052, LOT#3100973) WAS RECEIVED FOR EVALUATION. THE RETURNED AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX WAS MANUFACTURED IN APRIL 2009 AND IS OVER 4 YEARS OLD. THE AIMING ARM BODY COMPONENT (PART#03.010.052.01) FROM THE RETURNED AIMING ARM WAS MANUFACTURED FROM 7075 ALUMINUM AND HARDCOAT ANODIZED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE VA-LCP PROXIMAL TIBIAL PLATE RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION. NO DAMAGE OR BEND EXISTS ON THE RETURNED AIMING ARM. THIS COMPLAINT WAS CAUSED WHEN DAMAGE (DEEP BURRS ON DISTAL GROOVES) OCCURRED TO THE INSERTION HANDLE WHEN THE SURGEON OVER TIGHTENED THE DRIVING CAP WITH THE WRENCH PER THE COMPLAINT DESCRIPTION.

    Description of Event or Problem · 1

    DURING A TIBIAL NAIL PROCEDURE ON (B)(6) 2013, THE SURGEON ENCOUNTERED ISSUES WITH THE INSTRUMENTS. REPORTEDLY THE GUIDE WIRE HOLDING DEVICE WOULD NOT LOCK TO THE GUIDE WIRE EASILY, AND IT KEPT SLIPPING. SECONDLY, THE AIMING ARM OR INSERTION HANDLE BENT DURING THE PROCEDURE WHEN THE SURGEON OVER TIGHTENED THE DRIVING CAP WITH THE WRENCH. HE WAS UNABLE TO LOOSEN THE CAP UNTIL AFTER THE PROCEDURE WAS COMPLETED. INSTEAD, THE SURGEON HAD TO APPLY COUNTER-PRESSURE TO THE AIMING ARM AND INSERTION HANDLE TO REPOSITION THE DRIVING CAP. THE COUNTER-PRESSURE BENT EITHER THE AIMING ARM OR INSERTION HANDLE OR BOTH, AND THE DYNAMIC AND STATIC LOCKING SCREWS WOULD NOT LINE UP WITH THE HOLES IN THE NAIL CORRECTLY. SURGEON REMOVED THE AIMING ARM AND THE INSERTION HANDLE. THE NAIL WAS CORRECTLY PLACED AND REMAINED IMPLANTED. THE SURGEON COMPLETED THE PROCEDURE BY FREEHAND TIGHTENING OF THE DYNAMIC AND STATIC LOCKING SCREWS. LASTLY, THE STARDRIVE SCREWDRIVER ALSO BECAME STRIPPED WHILE TIGHTENING THE SCREWS. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272073 STANDARD INSERTION HANDLE LXH SYNTHES GMBH 3104483

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR