BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SHAFT, T-15, MEDIUM

    MDR report key: 8793555 · Received July 16, 2019

    Report

    Report Number
    1220246-2019-01207
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    June 26, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225190
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED FOR TWISTED AND BROKEN DRIVER TIP. THE DEFORMATION INDICATES THE DRIVER WAS TIGHTENING THE SCREW AND THE EVENT DESCRIPTION STATES A TORQUE LIMITING ADAPTER WAS NOT USED. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDES CONTINUALLY APPLYING TORQUE AFTER THE IMPLANT IS FULLY SEATED, APPLYING TORQUE WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, LEVERAGING, OR TORQUING WHILE LEVERAGING THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A RTSA PROCEDURE, AS THE SURGEON WAS INSERTING THE SUPERIOR LOCKING SCREW ON THE GLENOID BASEPLATE, THE TIP OF THE AR-9545-T15-02 DRIVER SHAFT (MEDIUM) BROKE OFF INTO THE HEAD OF THE SCREW. THE REP STATED THERE WAS NOT AN ATTEMPT MADE TO RETRIEVE THE BROKEN TIP AS THE STEM AND CUP WERE ALREADY ADEQUATELY TIGHTENED AND THE TIP OF THE DRIVER WAS NOT PROUD OF THE SCREW. THE BROKEN TIP WAS LEFT IN PLACE. THE CASE WAS COMPLETED AND A SECOND SURGERY IS NOT NEEDED. ADDITIONAL INFORMATION RECEIVED ON 07/15/2019: THE REP REPORTED THE BROKEN AR-9545-T15-02 WAS FROM LOT: 8001721. THERE ARE NO AVAILABLE PICTURES. THE TORQUE LIMITING ADAPTER WAS NOT USED FOR THE SUPERIOR LOCKING SCREW. THE SURGEON ONLY USED THE TORQUE DRIVER AND TRINITY GUIDE FOR INSERTION OF THE CENTRAL SCREW AND BASEPLATE. THE COMPLAINT DEVICE WILL BE RETURNING FOR EVALUATION. THE DRIVER WAS NOT USED ON POWER. THE REP STATED IT IS UNKNOWN HOW MANY SURGERIES THE AR-9545-T15-02 WAS USED IN PRIOR TO BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585923 DRIVER SHAFT, T-15, MEDIUM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T-15, MEDIUM UNK 00888867225190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other