BEUDAMED
    FDA Adverse Event Other Summary report: N

    2 D DRILL BIT

    MDR report key: 979783 · Received September 19, 2007

    Report

    Report Number
    979783
    Event Type
    Other
    Date Received
    September 19, 2007
    Date of Event
    July 24, 2007
    Report Date
    August 28, 2007
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTIFIED ON 08/28/07 THAT MFR OF DEVICE IS WRIGHT MEDICAL TECHNOLOGY INC. PATIENT UNDERWENT OPEN REDUCTION WITH INTERNAL FIXATION OF RIGHT AND CALCANEAL FRACTURE IN 2007. DRILL BIT FROM DARCO PLATE BROKE. THE DRILL BIT WAS RETRIEVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 D DRILL BIT DRILL BIT HTW WRIGHT MEDICAL TECHNOLOGY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other