BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER

    MDR report key: 2944945 · Received February 6, 2013

    Report

    Report Number
    1719045-2013-00263
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED. THE DEVICE WAS NOT RETURNED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS INJURED IN MVA IN (B)(6) 2012, RETURNED TO SURGEON ON (B)(6) 2013, FOR SCHEDULED PROCEDURE TO REMOVE A COMPETITOR'S EXTERNAL FIXATION DEVICE AND IMPLANT A HINDFOOT ARTHRODESIS NAIL. SURGEON IMPLANTED THE NAIL AND THEN DRILLED THE LATERAL CORTEX FOR PROXIMAL SCREWS. AFTER DRILLING, THE PROXIMAL SCREW WOULD NOT GO THROUGH THE NAIL. SURGEON CONFIRMED THAT THE CORRECT AIMING ARM WAS BEING USED. SURGEON REMOVED THE PROXIMAL SCREW AND THE GUIDE, REPOSITIONED THE AIMING ARM, RE DRILLED AND THEN PLACED THE SCREW FREEHAND; THE NAIL REMAINED IMPLANTED. PROCEDURE WAS COMPLETED, BUT SURGERY TIME WAS EXTENDED BY APPROXIMATELY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49705 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM F/IM NAIL-STER LOCKING SCREW HWC SYNTHES MONUMENT 6933490

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention EXTERNAL FIXATION DEVICE, NON SYNTHES.