BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTRLASSO SD SFT,45°RT CRV,R

    MDR report key: 24160279 · Received January 23, 2026

    Report

    Report Number
    1220246-2026-00288
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 8, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867035621
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 08TH JAN 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT SUTRLASSO SD SFT,45°RT CRV, R AR-5068-45R LOT 0072332 WAS BENT AND SUBSEQUENTLY BROKE DURING THE PROCEDURE PM (B)(6) 2026. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS USING A NEW (AR-5068-XX) WITH NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY AND NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210884 SUTRLASSO SD SFT,45°RT CRV,R ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. SUTRLASSO SD SFT,45°RT CRV,R 0072332 00888867035621

    Patients

    Seq Age Sex Outcome Treatment
    1