BEUDAMED
    FDA Adverse Event Other Summary report: N

    CANCELLOUS SCREWS

    MDR report key: 927247 · Received October 15, 2007

    Report

    Report Number
    MW5004057
    Event Type
    Other
    Date Received
    October 15, 2007
    Date of Event
    October 10, 2006
    Report Date
    September 5, 2007
    Manufacturer
    SYNTHES, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS COMPLAINING OF SYMPTOMATIC HARDWARE, SO THE DECISION TO REMOVE THE IMPLANTS WAS UNDERTAKEN. DURING SURGERY, THE SURGEON ATTEMPTED TO REMOVE THE LATERAL MOST SCREW. SHE WAS ABLE TO REMOVE THE SCREW; HOWEVER, WHEN THE SCREW WAS APPROX HALFWAY OUT, THE HARDWARE WAS NOTED TO FAIL AND THEREFORE ONLY THE SCREW AND NONTHREATED PORTION OF THE SCREW WAS REMOVED. ATTENTION WAS THEN TURNED TO THE MEDIAL SCREW. THE PROCEDURE WAS REPEATED AND THE SAME RESULT OCCURRED, WITH FAILURE OF THE HARDWARE. THUS, ONLY THE SCREW HEAD AND THE NONTHREATED PORTION OF THE SCREW WERE ABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLOUS SCREWS KNEE SCREWS HWC SYNTHES, INC. SML. FRAG. 1-007-02

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other