BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATH HEAVY WEIGHT MALLET

    MDR report key: 2666701 · Received July 13, 2012

    Report

    Report Number
    3007208013-2012-00002
    Event Type
    Malfunction
    Date Received
    July 13, 2012
    Date of Event
    May 31, 2012
    Report Date
    July 12, 2012
    Manufacturer
    SYMMETRY SURGICAL FORMERLY SURGICAL INSTRUMENTATION
    Product Code
    GFJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A TOTAL HIP REPLACEMENT, THE SURGEON WAS USING A MALLET, WHEN THE HEAD OF THE MALLET CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEATH HEAVY WEIGHT MALLET GFJ SYMMETRY SURGICAL FORMERLY SURGICAL INSTRUMENTATION 27-0880 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other