BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 18710202 · Received February 15, 2024

    Report

    Report Number
    1220246-2024-00978
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 25, 2024
    Report Date
    December 2, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 COMPLAINT CONFIRMED. ONE UNPACKED AR-8737-38 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION FOUND THAT THE HEX TIP OF THE DRIVER WAS BROKEN OFF. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE DAMAGE TO THE DEVICE. A TORQUE-LIMITING HANDLE OR MODULAR TORQUE-LIMITING ADAPTER IS RECOMMENDED FOR USE WITH THE DEVICE TO PREVENT OVER-TORQUING. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USE ERROR OVER-TORQUING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 01/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING A PROCEDURE ON (B)(6) 2024, WHILE REMOVING HARDWARE FROM THE PATIENT, TWO T10 HEXALOBE DRIVERS, AR-8737-38, BROKE. THE CASE WAS COMPLETED WITH A BACKUP DRIVER WITH NO ADVERSE EFFECT TO THE PATIENT. NO FURTHER DETAILS WERE PROVIDED; ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 2/5/2024: THE DRIVERS BROKE WHILE TORQUING. NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 5 MINUTES AS THERE WERE MORE DRIVERS ON HAND. THIS OCCURRED DURING A REVISION PROCEDURE WHEN EXPLANTING ARTHREX PRODUCTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503888 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1392109 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown