BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M/DN INTRAMEDULLARY FIXATION DISTAL DRILL

    MDR report key: 1812423 · Received August 17, 2010

    Report

    Report Number
    1822565-2010-00596
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 20, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    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 SURGEON WAS PERFORMING AN IM NAIL PROCEDURE ON THE PATIENT. WHILE DRILLING THE DISTAL HOLE IN THE BONE, THE DRILL BIT FRACTURED IN THE PATIENT'S BODY. ATTEMPTS TO RETRIEVE THE FRACTURED PORTION FROM THE BONE WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/DN INTRAMEDULLARY FIXATION DISTAL DRILL TRAUMA INSTRUMENT LXH ZIMMER, INC. 60639042

    Patients

    Seq Age Sex Outcome Treatment
    1