BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM HEX DRIVER

    MDR report key: 19750560 · Received July 16, 2024

    Report

    Report Number
    1220246-2024-06768
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, 3.0 MM HEX DRIVER, AR-9625, BATCH 022243, WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INVESTIGATION IT WAS NOTED THAT DISTAL TIP OF THE DEVICE HAD BROKEN, AND THE TIP OF THE DEVICE WAS WARPED/STRIPPED. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 6/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT (QTY. 2) OF AN AR-9625 3.0 MM HEX DRIVER WERE BROKEN WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/25/2024: THE TIP IS WARPED ON ONE AND BROKEN ON THE OTHER. THIS WAS DISCOVERED DURING A REVERSE TSA PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED WHEN THEY WERE DONE USING THE DEVICE. THERE WAS NO CASE DELAY. ADDITIONAL INFORMATION WAS RECEIVED ON 7/2/2024: THE REP COULD NOT CONFIRM WHICH AR-9625 3.0 MM HEX DRIVER WAS BROKEN AND WHICH ONE WAS WARPED. ALL FRAGMENTS WERE RETRIEVED OF THE BROKEN AR-9625 3.0 MM HEX DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738939 3.0MM HEX DRIVER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 3.0MM HEX DRIVER 022243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown