BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 2950086 · Received February 6, 2013

    Report

    Report Number
    2530088-2013-10047
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2011
    Report Date
    January 8, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW PERFORMED: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. DEVICE RECEIVED WITH SIGNIFICANT SCRATCHES ON TOP NEAR THE BORE AND SIGNIFICANT DENTS AND SCRATCHING AT THE NOTCH. THE TANG IS ALSO DENTED AND SCRATCHED. DEVICE PASSED CURRENT FUNCTIONAL TEST WITH MEASURES HOLE SIZES PERPENDICULARITY AND POSITION. ALLEGED ISSUE NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TFN PROCEDURE, THERE WAS A MISALIGNMENT ISSUE. THE LOCKING SCREW WAS NOT LINING UP. THE JIG WAS REMOVED TO COMPLETE THE SURGERY FREE HAND. SURGERY TIME WAS EXTENDED LESS THAN ONE HOUR. THIS IS 8 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50749 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS FZX SYNTHES (USA) BRANDYWINE 4826349

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention