BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE FIXATION DRILL

    MDR report key: 1378626 · Received March 6, 2009

    Report

    Report Number
    1822565-2009-00234
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    January 27, 2009
    Report Date
    January 28, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 DR WAS DRILLING HOLES TO PASS SUTURE AND REATTACH WHEN THE DRILL BIT BROKE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR