BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER INSTRUMENT

    MDR report key: 1350635 · Received February 13, 2009

    Report

    Report Number
    1644408-2009-00068
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    January 20, 2009
    Report Date
    January 20, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUMERAL BROACH HANDLE BROKE WHILE THE SURGEON WAS REMOVING THE HUMERAL BROACH. A PIECE OF THE INNER SLEEVE CLEANLY BROKE ON THE HUMERAL BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOULDER INSTRUMENT HUMERAL BROACH HANDLE HTQ ENCORE MEDICAL, L.P. 32569L07

    Patients

    Seq Age Sex Outcome Treatment
    1