BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TM REVERSE SHOULDER DRILL

    MDR report key: 4110699 · Received September 16, 2014

    Report

    Report Number
    1822565-2014-01132
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRILL BIT CONTAINED BLACK CALIBRATION MARKS ONLY AROUND 50% OF SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572306 ZIMMER TM REVERSE SHOULDER DRILL HSD ZIMMER, INC. 62631493

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR