BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER INSTRUMENT

    MDR report key: 1934469 · Received November 23, 2010

    Report

    Report Number
    1644408-2010-00639
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - THE BROACH HANDLE BROKE DURING SURGERY. SURGERY BEGAN AS SCHEDULED, BUT THE BROKEN HANDLE DID SIGNIFICANTLY LENGTHEN THE SURGERY BECAUSE IT WAS HARD TO REMOVE THE STEM. SURGERY WAS COMPLETED AND NO HARM WAS CAUSED TO THE PATIENT. THE SURGEON WOUND UP GETTING THE STEM OUT WITH VICEGRIPS AND A MALLET.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1