BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER INSTRUMENTATION

    MDR report key: 1550981 · Received November 23, 2009

    Report

    Report Number
    1644408-2009-00531
    Event Type
    Malfunction
    Date Received
    November 23, 2009
    Date of Event
    October 28, 2009
    Report Date
    October 28, 2009
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RSP PRIMARY SURGERY, ROTATOR CUFF ARTHROPLASTY. DJD. GLENOSPHERE INSERTER/IMPACTOR BROKE AT THREADS WHILE INSERTING GLENOSPHERE HEAD. TIP/THREADS OF INSERTER WERE LIFT IN PT/HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER INSTRUMENTATION GLENOID HEAD INSERTER/IMPACTOR HWA ENCORE MEDICAL, L.P. 35075L01A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR