BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNI FLEXIBLE BAYONET DRILL DRIVER

    MDR report key: 1271480 · Received December 19, 2008

    Report

    Report Number
    1226188-2008-00036
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    November 17, 2008
    Report Date
    December 19, 2008
    Manufacturer
    OMNI LIFE SCIENCES INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: FLEXIBLE PART OF THE DRIVER TWISTED AND BENT EITHER FROM REVERSING THE DRILL, OR EXCESS TORQUE APPLIED. FLEXIBLE DRIVERS HAVE A LIMITED LIFETIME AND THIS IS A COMMON FAILURE MODE.

    Description of Event or Problem · 1

    DURING TOTAL HIP ARTHROSCOPY AN ACETABULAR FLEXIBLE DRIVER BROKE, CAUSING A 15 MINUTE DELAY IN SURGERY. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI FLEXIBLE BAYONET DRILL DRIVER FLEXIBLE DRIVER LXH OMNI LIFE SCIENCES INC. 2567150001

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR