BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER

    MDR report key: 2102076 · Received April 14, 2011

    Report

    Report Number
    1644408-2011-00191
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - THE REAMER BECAME CAUGHT ON THE THREADS OF THE TAP AND BENT THE THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER REAMER BONE TAP SHOULDER GUIDE HWX ENCORE MEDICAL, L.P. 39580101

    Patients

    Seq Age Sex Outcome Treatment
    1