BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMP HIP

    MDR report key: 1860057 · Received September 17, 2010

    Report

    Report Number
    1644408-2010-00490
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE DRILL SHAFT UNWOUND WHILE USING THE DRILL ON FORWARD POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMP HIP FLEX SHAFT, INSTRUMENT HTW ENCORE MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 200 YR