BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY-OUT, MINI/STANDARD COMPRESSION FT

    MDR report key: 23368414 · Received October 23, 2025

    Report

    Report Number
    1220246-2025-04781
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 16, 2025
    Report Date
    October 23, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REMOVAL OF AN ARTHREX PLATE THE TIP OF THE SCREWDRIVER BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835329 EASY-OUT, MINI/STANDARD COMPRESSION FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT 1391942 00888867263833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown