BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2 FEMORAL NAIL

    MDR report key: 1872990 · Received October 6, 2010

    Report

    Report Number
    1872990
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER ORTHOPEDICS
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING SURGERY A DRILL BIT BROKE WHILE BEING USED. ALL THE PIECES WERE RETRIEVED AND THE BROKEN AREA OF THE DRILL BIT WAS OUTSIDE OF THE PT. AT THE TIME OF THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T2 FEMORAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES, DRILL BIT HSB STRYKER ORTHOPEDICS 1806-4270S K296985

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR