BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE FIXATION DRILL BIT

    MDR report key: 3151364 · Received May 30, 2013

    Report

    Report Number
    1822565-2013-00882
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    March 9, 2013
    Report Date
    April 30, 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

    INFORMATION WAS RECEIVED VIA MEDWATCH (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION S COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRILL BIT BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238507 ECT INTERNAL FRACTURE FIXATION DRILL BIT TRAUMA INSTRUMENT HTW ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR