BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER INSTRUMENT

    MDR report key: 1883223 · Received October 20, 2010

    Report

    Report Number
    1644408-2010-00556
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - WHILE PUTTING THE TAP INTO THE GLENOID VIA POWER, DURING A REVERSE TOTAL SHOULDER PROCEDURE, THE POWER ADAPTER BROKE INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER INSTRUMENT POWER TAP HWX ENCORE MEDICAL, L.P. 37851L09

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR