BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRILL BIT

    MDR report key: 1073984 · Received July 3, 2008

    Report

    Report Number
    1043534-2008-00164
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 17, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ADD'L INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    ALLEGEDLY ONCE THE COUNTERSINK HAD BEEN DRIVEN INTO THE BONE, THE WIRE BROKE, WITH APPROX 20MM LEFT IN THE BONE. THE BONE STOCK WAS NOT PARTICULARLY SCLEROTIC. IN ORDER TO REMOVE THE PIECES OF WIRE IN THE PT, A LONG 2.0MM CANNULATED DRILL WAS USED TO OVER DRILL THE WIRE, THEN PUSH OUT THE WIRE WITH A SECOND 1.6MM WIRE. THIS EXTRA PROCEDURE OF WIRE REMOVAL ADDED 20 MIN. TO A 40 MIN. CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT LXH WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention