BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 19740238 · Received July 15, 2024

    Report

    Report Number
    1220246-2024-06738
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 21, 2024
    Report Date
    September 20, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263765
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP OF THE RETURNED DRIVER SHAFT, T15 HEXALOBE, CANNULATED, ISO, AO, HAD BROKEN OFF. NO BROKEN PIECES WERE RETURNED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGED DISTAL TIP OF THE DEVICE. 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 6/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-8770-01 DRIVER SHAFT (COMPONENT SET OF AR-8750S LOT 15187400) SNAPPED DURING USE AND ALL FRAGMENTS WERE RETRIEVED, AND AN AR-8750-03 DRIVER SHAFT SNAPPED DURING USE AND ALL FRAGMENTS WERE RETRIEVED. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209095 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. 1392151 00888867263765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown