BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1212386 · Received October 20, 2008

    Report

    Report Number
    1212386
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING TOTAL HIP ARTHROPLASTY WHEN A ZIMMER DRILL BIT BROKE DURING USE. SURGEON TRANSCRIBED DURING THE DRILLING OF ONE OF THE HOLES THROUGH THE GREATER TROCHANTER FOR SECURING HIS EXTERNAL ROTATORS WHEN IT WAS NOTED THAT THE DRILL BIT WAS BROKEN. SURGEON NOR STAFF REMEMBER ANY TIME IN WHICH THE DRILL BIT WAS TORQUED AND COULD NOT FIND ANYTHING UPON INSPECTION IN THE CAVITY OR SURGICAL FIELD. AN X-RAY OBTAINED UNDER FLUOROSCOPY AND WAS SHOT ACROSS MULTIPLE PLANES. THE BIT WAS UNABLE TO BE LOCATED. THE X-RAY WAS CLEAR OF ANY RETAINED FRAGMENT/FOREIGN OBJECTS. THERE WAS NO INJURY TO PATIENT. THE DRILL BIT IS A ONE TIME USE ITEM. PATIENT WAS SENT TO RECOVERY AND APPEARS TO BE DOING WELL. IT HAS BEEN DETERMINED THESE DRILL BITS ARE MAINTAINED AND SERVICED BY ZIMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DISPOSABLE DRILL BIT HTW ZIMMER, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR