BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 21618656 · Received March 17, 2025

    Report

    Report Number
    1220246-2025-00956
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 27, 2025
    Report Date
    August 28, 2025
    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

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. PHOTOGRAPHIC EVIDENCE PROVIDED FROM THE FIELD OF AN UNPACKAGED AR-8750-03, WITH BATCH NUMBER 1392339, REVEALED A DAMAGED/TWISTED HEX TIP. THEREFORE, ARTHREX WAS ABLE TO DEDUCE THE CAUSE OF THE COMPLAINT AS WEAR AND TEAR. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR, WHICH RESULTS FROM EXCESSIVE STRESS ON A DEVICE THAT HAS NATURALLY DETERIORATED OVER TIME DUE TO NORMAL USAGE AND AGING.

    Description of Event or Problem · 0

    ON 02/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT 2 AR-8750-03 HEXALOBE DRIVER SHAFT TIP IS TWISTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO PIECE BROKE OFF INSIDE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1210978 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. 1392339 00888867263765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown