BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 20599334 · Received November 4, 2024

    Report

    Report Number
    1220246-2024-08382
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 2, 2024
    Report Date
    December 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263765
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    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

    ADDITIONAL INFORMATION: B5, D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-8750-03, DRIVER SHAFT, T15 HEXALOBE, BATCH 1392327, WAS RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, NOTED THAT THE DISTAL TIP OF THE INSERTER SHAFT WAS BROKEN. NO BROKEN PIECES WERE RETURNED FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE, AS THE DRIVER SHOULD NOT BE USED FOR REMOVAL OF THE SCREW.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8750-03 DRIVER SHAFT, T15 HEXALOBE, CANNULATED HAD THE TIP OF THE SCREW BREAK OFF IN THE HEAD OF THE SCREW WHEN THE SURGEON WAS TRYING TO BACK OUT THE SCREW. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO PIECES BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 11/04/2024: THERE WAS NO CASE DELAY. THE HARDWARE REMOVAL PROCEDURE WAS FOR THE REMOVAL OF THE ARTHREX PART AR-8750-50H 5.0 LARGE COMPRESSION FT SCREW, WHICH WAS EXPLANTED DURING THE SURGERY. AT THIS TIME, IT IS UNKNOWN WHY THE PATIENT UNDERWENT REVISION SURGERY. NO ARTHREX PRODUCTS WERE IMPLANTED DURING THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631050 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. 1392327 00888867263765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown