BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION SHOULDER INSTRUMENT

    MDR report key: 1880511 · Received October 13, 2010

    Report

    Report Number
    1644408-2010-00535
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT END OF LIFE-BROACH HANDLE BROKE WHEN REMOVING AN IMPACTED BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER INSTRUMENT HUMERAL STEM/BROACH INSTRUMENT HTQ ENCORE MEDICAL, L.P. 33916L01 / 34508L02

    Patients

    Seq Age Sex Outcome Treatment
    1 804-00-140, LOT 34508L02