BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 2810268 · Received October 31, 2012

    Report

    Report Number
    2530088-2012-00965
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 28, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KTT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE CAP IS SEPARATED FROM THE SHAFT AT THE WELD LOCATION. THERE IS DAMAGE TO THE HEX DRIVE ON THE CAP AND THERE ARE IMPACT MARKS ON THE TOP OF THE CAP. THE SHAFT DOESN'T APPEAR TO HAVE ANY MAJOR DAMAGE. EXCESSIVE FORCE WAS USED ON THE HEAD OF THE COUPLING SCREW WHICH COULD HAVE LED TO ITS BREAKAGE. THE DEVICE CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE DEVICE MET ALL DESIGN AND MANUFACTURING REQUIREMENTS. THE RISK ANALYSIS ADEQUATELY ADDRESSES THE REPORTED EVENT AND THE DESIGN OF THE DEVICE WAS EVALUATED AND DEEMED TO MEET ITS INTENDED USE. THE TECHNIQUE GUIDE RECOMMENDS VERIFICATION OF THE POSITION OF THE LOCKING MECHANISM AFTER THE INSERTION INSTRUMENTATION HAS BEEN CONNECTED TO THE NAIL.

    Description of Event or Problem · 1

    HOSPITAL IN (B)(6) REPORTS THAT DURING A TFN PROCEDURE THE HELICAL BLADE JAMMED DURING INSERTION. THE SURGEON USED HEAVY HAMMER HITS TO TRY TO ADVANCE THE BLADE AND THE COUPLING SCREW BROKE. THE SURGEON REMOVED THE NAIL AND THE BLADE AND IMPLANTED A LATERAL FEMORAL NAIL INSTEAD. THIS REPORT IS #3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELICAL BLADE COUPLING SCREW HELICAL BLADE COUPLING SCREW KTT SYNTHES BRANDYWINE 5658341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NAIL, BLADE