BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES, INC.

    MDR report key: 2215647 · Received August 12, 2011

    Report

    Report Number
    MW5021749
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 2, 2011
    Manufacturer
    SYNTHES, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT OPEN REDUCTION INTERNAL FIXATION OF PROXIMAL FEMUR FRACTURE. DURING THE PROCEDURE, 4.3MM PIECE OF DRILL BIT BROKE OFF AND WAS RETAINED IN THE HOLE. ANTERIOR AND POSTERIOR X RAYS CONFIRMED THE RETAINED PIECE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR