BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 18139954 · Received November 15, 2023

    Report

    Report Number
    1220246-2023-08746
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 22, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. TWO UNPACKED AR-8737-38 SERIAL/BATCH NUMBER (B)(6) WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF BOTH DRIVERS FOUND: DRIVER#1 THE HEX TIP WAS BROKEN OFF AND TWISTED. DRIVER#2 THE DRIVER HEX TIP WAS CRACKED AND TWISTED. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE DAMAGE TO THE DEVICES. IT WAS NOT INDICATED IF A TORQUE-INDICATING ADAPTER HAD BEEN USED WITH THE DEVICE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-8737-38 HEX DRIVER SHAFT TIPS BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 10/20/2023: THIS WAS DISCOVERED DURING A FOURTH METACARPAL IM SCREW PROCEDURE. UPON INSERTING THE SCREW IN THE ISTHMUS OF THE CANAL, BOTH HEX DRIVER TIPS BROKE OFF. THE SCREWS WERE REMOVED EACH TIME THE DRIVER TIP BROKE, RE-REAMED, AND NEW SCREWS WERE INSERTED WITH A NEW AR-8737-38 HEX DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907084 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1392316 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown