BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SHAFT, T-15, SHORT

    MDR report key: 7625827 · Received June 21, 2018

    Report

    Report Number
    1220246-2018-00520
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    June 5, 2018
    Report Date
    August 29, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. THE EVALUATION REVEALED THE DISTAL TIP WAS BROKEN OFF AND THE HEX WAS TWISTED. THE DEVICE MET ALL MATERIAL SPECIFICATIONS AS RECEIVED. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE CONTINUALLY APPLYING TORQUE WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, LEVERAGING, TORQUING WHILE LEVERAGING THE DEVICE, AND/OR USING THE INCORRECT SCREW WITH THE DRIVER WHICH MAY RESULT IN SCREW NOT FULLY SEATING ON DRIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE, THE SURGEON WAS INSERTING THE SUPERIOR PERIPHERAL SCREW WITH THE SHORT DRIVER SHAFT, LOT: 8001545. THE SURGEON DID NOT USE THE TORQUE LIMITING ADAPTOR DURING THIS PROCESS. THE TIP OF THE DRIVER BROKE OFF AND COLD-FUSED TO THE HEAD OF THE SCREW AND WAS UNABLE TO BE RETRIEVED. THE SCREW WAS DOWN FAR ENOUGH FOR THE GLENOSPHERE TO FIT PERFECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467419 DRIVER SHAFT, T-15, SHORT INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. DRIVER SHAFT, T-15, SHORT 8001545

    Patients

    Seq Age Sex Outcome Treatment
    1 Other