BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHROTEK

    MDR report key: 745497 · Received July 17, 2006

    Report

    Report Number
    MW1039776
    Event Type
    Other
    Date Received
    July 17, 2006
    Date of Event
    June 28, 2006
    Report Date
    July 14, 2006
    Manufacturer
    BIOMED ORTHOPEDICS
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DRILLING WITH APPROPRIATE DRILL BIT, THE TAP WAS ADVANCED AFTER THE DEPTH GAUGE MEASURED APPROX A 45 MM SCREW. THE TAP FRACTURED JUST AS THE DISTAL CENTER OF THE TIBIA WAS ENTERED. A SCREW REMOVAL SET WAS USED TO REMOVE THE TAP. A 4.5 CANCELLOUS SCREW WAS THEN USED. PT TOLERATED PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROTEK RESERVABLE BONE SCREW 4.0 HWX BIOMED ORTHOPEDICS 410 048240

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other