BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX®

    MDR report key: 24965536 · Received April 23, 2026

    Report

    Report Number
    24965536
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 15, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING AN ORTHOPEDIC PROCEDURE, THE TIP OF THE ATHREX AR-18800-03 DRIVER SHAFT, T6, BROKE OFF WITHIN THE SCREW HEAD OF A LOCKING SCREW. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE TIP WERE UNSUCCESSFUL. THE SURGEON ELECTED TO LEAVE THIS IN PLACE AS IT HAD EFFECTIVELY COLD WELDED INTO THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460792 ARTHREX® ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. AR-18800-03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other