BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION KNEE

    MDR report key: 1853788 · Received September 3, 2010

    Report

    Report Number
    1644408-2010-00474
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE IMPACTOR INSTRUMENT BROKE IN HALF WHILE HAMMERING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE IMPACTOR BLOCK, FEMORAL/TIBIAL HWA ENCORE MEDICAL, L.P. 36967L34

    Patients

    Seq Age Sex Outcome Treatment
    1