BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER INSTRUMENT

    MDR report key: 1203474 · Received October 17, 2008

    Report

    Report Number
    1644408-2008-00362
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THREADS ARE NO LONGER ON BROACH. BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER INSTRUMENT HANDLE, HUMERAL BROACH HTQ ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention