BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SHAFT, T-15, SHORT

    MDR report key: 9376451 · Received November 26, 2019

    Report

    Report Number
    1220246-2019-01439
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    October 30, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225183
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLLOWING DRIVER SHAFTS, AR-9545-T15-01 / LOT: 8001724 AND AR-9545-T15-02 / SN: (B)(4), BECAME WARPED / STRIPPED / BROKEN DURING A CASE. WHILE ATTEMPTING TO ENGAGE THE LOCKING SCREW INTO THE UNIVERSE REVERS CONVERTIBLE BASEPLATE, THE HEADS OF EACH T-15 DRIVER TIP BECOME TWISTED / BROKE. ADDITIONAL INFORMATION OBTAINED ON 11/07/2019: THE TIP OF THE AR-9545-T15-01 / LOT: 8001724, BROKE OFF INTO THE SCREW HEAD. THE SURGEON FELT IT WAS OKAY TO LEAVE IT BECAUSE IT COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170679 DRIVER SHAFT, T-15, SHORT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T-15, SHORT 8001724 00888867225183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other