BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIKDRIVE BATTERY POWERED SCREWDRIVER MINI

    MDR report key: 1922716 · Received November 12, 2010

    Report

    Report Number
    8010177-2010-00429
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER SALES REP: WHEN I ATTACHED THE BATTERY, MY INITIAL THOUGHT WAS IT WAS EITHER A DEAD BATTERY OR A DEAD HAND PIECE. THEN A FEW SECONDS LATER, THE CONTROLS JUST TOOK OFF WITHOUT ME TOUCHING THE FORWARD OR REVERSE BUTTONS. THEN IT JUST STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIKDRIVE BATTERY POWERED SCREWDRIVER MINI INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK