BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXATION DRILL BIT

    MDR report key: 1590942 · Received January 26, 2010

    Report

    Report Number
    MW5014553
    Event Type
    Malfunction
    Date Received
    January 26, 2010
    Date of Event
    January 22, 2010
    Report Date
    January 26, 2010
    Manufacturer
    MEDARTIS, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING AN OPEN REDUCTION INTERNAL FIXATION OF FRACTURED RIGHT THIRD METACARPAL FOLLOWED BY MANIPULATIVE REDUCTION AND PERCUTANEOUS PINNING OF THE PROXIMAL FOURTH AND FIFTH METACARPAL FRACTURES. WHILE USING THE DRILL BIT DURING THE COURSE OF THE SURGERY, THE TIP BROKE AND LODGED IN THE PT'S BONE FLUSH TO THE FIXING PLATE. THIS COULD NOT BE RETRIEVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXATION DRILL BIT FIXATION DRILL BIT HTW MEDARTIS, INC. A-3230

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR