BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY-OUT, MINI/STANDARD COMPRESSION FT

    MDR report key: 22296588 · Received June 20, 2025

    Report

    Report Number
    1220246-2025-02577
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DISTAL END OF THE SHAFT WAS BROKEN, AND THE THREADS WERE DAMAGED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. PER DFU-0023-EO CAUTIONS: TO AVOID DAMAGING THE INSTRUMENTS, DO NOT IMPACT OR SUBJECT TO BLUNT FORCE ANY INSTRUMENTS THAT ARE DESIGNED TO BE TURNED OR SCREWED IN. WHEN TWO DEVICES ARE INTENDED TO BE THREADED TOGETHER, ENSURE THAT THEY ARE FULLY ENGAGED PRIOR TO USE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO OVER-TORQUING/OVER-ENGAGING APPLYING EXCESSIVE MECHANICAL FORCES DURING INSERTION/USE.

    Description of Event or Problem · 0

    ON 05/29/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8737-62 MINI EASY-OUT SCREW REMOVER TIP BROKE OFF DURING A CASE, AND NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640486 EASY-OUT, MINI/STANDARD COMPRESSION FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT 1392434 00888867263833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown