BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIMAX

    MDR report key: 647081 · Received November 3, 2005

    Report

    Report Number
    647081
    Event Type
    Malfunction
    Date Received
    November 3, 2005
    Date of Event
    November 27, 2005
    Report Date
    November 3, 2005
    Manufacturer
    DUPUY MITEK, A JOHNSON AND JOHNSON COMPANY
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    IN THE PROCESS OF DOING A TROCHANTERIC NAILING OF RIGHT HIP THE DISTAL SCREW BEING INSERTED BY MD, A 4.5 CORTICAL SCREW, BROKE. BROKEN HEAD OF THE SCREW WAS RECOVERED BUT A PORTION OF IT REMAINED EMBEDDED AND WAS HOLDING THE DISTAL ENDOF THE TROCHANTERIC NAIL. MD DECIDED TO LEAVE THE REMAINDER OF THE SCREW FOR IT WAS HOLDING THE NAIL IN PLACE AND WAS SERVING ITS PURPOSE. DE PUY SALES REPRESENTATIVE WAS PRESENT DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIMAX TROCHANTERIC SCREW HWC DUPUY MITEK, A JOHNSON AND JOHNSON COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *