BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SHAFT, T-15, MEDIUM

    MDR report key: 10414311 · Received August 17, 2020

    Report

    Report Number
    1220246-2020-02037
    Event Type
    Injury
    Date Received
    August 17, 2020
    Date of Event
    July 29, 2020
    Report Date
    September 16, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225190
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. VISUAL INSPECTION IDENTIFIED THAT THE DRIVE GEOMETRY OF THE RETURNED AR-9545-T15-02 HAD BROKEN. THE PATTERN ACROSS THE BREAKAGE SITE SUGGESTED THAT THE DEVICE BROKE UNDER TORSIONAL STRAIN. THIS IS FURTHER COMPOUNDED BY THE OBSERVATION THAT THE DRIVE SHAFT WAS NOTICEABLY TWISTED. IT WAS RECORDED THAT A TORQUE INDICATING ADAPTER WAS NOT USED WITH THE AR-9545-T15-02, WHICH IS RECOMMENDED TO PREVENT OVER-TORQUING.

    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 A TSA/ UNIVERSE SHOULDER WITH UNIVERSE BASEPLATE PROCEDURE TOOK PLACE (B)(6) 2020. WHILE IMPLANTING AN AR-9145-30 SCREW THE TIP OF THE DRIVER, AR-9545-T15-02 (LOT 8001716), BROKE OFF IN THE SCREW - FLUSH WITH THE HEAD OF THE SCREW. THE DRIVER TIP WAS LEFT IN THE SCREW AND REMAINED IN THE PATIENT. NO ATTACHMENT OR ADAPTER WAS USED WITH THE DRIVER. NO ADDITIONAL INCISIONS OR CHANGE OF TECHNIQUES WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881250 DRIVER SHAFT, T-15, MEDIUM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T-15, MEDIUM 00888867225190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other