BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 24400248 · Received February 20, 2026

    Report

    Report Number
    1220246-2026-00691
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    December 31, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867196322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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

    ON 04-FEB-2026, IT WAS REPORTED BY N ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-12990 KNEE SCORPION HAD A BROKEN NEEDLE IN THE INSTRUMENT AND WAS NOT WORKING PROPERLY. NO CASE INVOLVEMENT WAS REPORTED. ADDITIONAL INFORMATION PROVIDED 06-FEB-2026: IT WAS FURTHER REPORTED THIS DISCOVERED DURING USE IN A PROCEDURE WITH NO PATIENT HARM. WHEN ATTEMPTING TO USE THE INSTRUMENT, IT WAS NOT POSSIBLE TO DO SO, AND THE CASE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462362 UNK MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. UNK UNK 00888867196322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown