BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE DRILL BIT

    MDR report key: 3458236 · Received October 11, 2013

    Report

    Report Number
    1822565-2013-01456
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    August 28, 2013
    Report Date
    September 12, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. USER FACILITY MEDWATCH NUMBER (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRILL BIT FRACTURED WHILE DRILLING. THE FRAGMENT WAS REMOVED FROM THE PT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521776 ECT INTERNAL FRACTURE DRILL BIT HTW ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR