BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE DRILL BIT

    MDR report key: 3338931 · Received August 22, 2013

    Report

    Report Number
    1822565-2013-01254
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 FRACTURED. ALL PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408378 ECT INTERNAL FRACTURE DRILL BIT HTW ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR