BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3MM X 8MM

    MDR report key: 863565 · Received June 8, 2007

    Report

    Report Number
    1220246-2007-00087
    Event Type
    Other
    Date Received
    June 8, 2007
    Date of Event
    May 9, 2007
    Report Date
    June 5, 2007
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONFIRMED THE TIP HAS BROKEN OFF AT AN ANGLE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, DEVICE HISTORY COULD NOT BE REVIEWED AND MANUFACTURING DATE NOT DETERMINED. THE SHAFT DIAMETER WAS MEASURED AND FOUND WITHIN SPECIFICATIONS. MATERIAL VERIFICATION OF THE DRIVER WAS ALSO PERFORMED. FROM THE CONDITION OF THE DRIVER IT APPEARS THAT LEVERAGE OF THE DEVICE DURING USE CAUSED THE EVENT.

    Description of Event or Problem · 1

    DRIVER TIP BROKE INSIDE THE IMPLANT ON INSERTION DURING A HAND PROCEDURE. RETRIEVAL OF THE BROKEN PIECE WAS ATTEMPTED BUT NOT SUCCESSFUL AND REMAINS INSIDE THE IMPLANT IN PATIENT. THE HOSPITAL REPORTED NO ADVERSE CONSEQUENCES WITH THE PATIENT AS A RESULT OF THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3MM X 8MM DRIVER FOR BIO-TENODESIS SCREW HWC ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other