BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 18436241 · Received January 3, 2024

    Report

    Report Number
    1220246-2024-00037
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    November 30, 2023
    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
    ME, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF FURTHER INFORMATION.

    Description of Event or Problem · 0

    ON 12/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8737-38 T10 HEX DRIVER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761744 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT UNK 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown