BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP INSTRUMENTATION

    MDR report key: 1203477 · Received October 17, 2008

    Report

    Report Number
    1644408-2008-00367
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE T-HANDLE TIP BROKE OFF IN THE GLENOID HEAD IMPLANT AS THE SURGEON WAS TAPPING ON THE BACK OF THE T-HANDLE TO IMPACT THE GLENOID IMPLANT, ON THE TAPER OF THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP INSTRUMENTATION GLENOID HEAD INSERTER/IMPACTOR HWA ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 508-36-103