BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SHAFT, T-15, LONG

    MDR report key: 8670896 · Received June 5, 2019

    Report

    Report Number
    1220246-2019-01132
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 5, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225176
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED, THE DISTAL END WAS FOUND TO BE TWISTED AND TO HAVE A .060 PIECE BROKEN FROM THE DEVICE. IT IS STATED A TORQUE INDICATING ADAPTER WAS USED WHICH IS RECOMMENDED TO PREVENT OVER-TORQUING. AS THE DEVICE WAS FOUND TO MEET DIMENSIONAL AND MATERIAL SPECIFICATIONS, THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE CONTINUALLY APPLYING TORQUE WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, LEVERAGING, OR TORQUING WHILE LEVERAGING THE DEVICE AND/OR IMPROPER USE OF THE TORQUE INDICATING ADAPTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLLOWING OCCURRED DURING A REVISION PROCEDURE TO REMOVE A COMPETITOR¿S DEVICE (ARTHROSURFACE HEMI CAP). AFTER REMOVAL OF THE COMPETITOR¿S DEVICE A REVERSE TOTAL SHOULDER PROCEDURE WAS THEN PERFORMED. DURING THE PROCEDURE AN ARTHREX AR-1999HH (RATCHETING HANDLE), LOT 8001640 WAS NOT RATCHETING CORRECTLY AND COULD NOT BE USED. WHILE BEING USED TO INSERT A CENTRAL SCREW, AN AR-9545-T15-03 (DRIVER SHAFT), LOT 8001643, TIP BROKE OFF IN THE HEAD OF THE SCREW. THE TIP WAS NOT RETRIEVED AND IT REMAINS IN THE SCREW IN THE PATIENT. AN AR-9545-T15-02, (DRIVER SHAFT), LOT 8001819, WAS ALSO USED AND IT WAS REPORTED THAT THE THREADS OF THE DRIVER WERE TWISTED WHEN TIGHTENING THE SUPERIOR SCREW. THE SUPERIOR PERIPHERAL SCREW AR-9145-42NL, LOT UNKNOWN, SNAPPED OFF AT THE SHAFT AND HALF OF THE SCREW WAS LEFT IN THE PATIENT UNRETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463871 DRIVER SHAFT, T-15, LONG ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T-15, LONG 8001643 00888867225176

    Patients

    Seq Age Sex Outcome Treatment
    1 Other