BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMP SWVLK C, CLD 4.75X19.1MM

    MDR report key: 24499655 · Received March 3, 2026

    Report

    Report Number
    1220246-2026-01178
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 3, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867026827
    PMA / PMN Number
    K203495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 11-FEB-2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C ANCHOR BROKE DURING INSERTION OF THE SWIVELOCK. THE ISSUE WAS IDENTIFIED INTRAOPERATIVELY ON (B)(6) 2026, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-FEB-2026: DURING A SUBSCAPULARIS REPAIR PROCEDURE, THE THREADS OF AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C ANCHOR STRIPPED UPON INSERTION. ALL ASSOCIATED FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE SURGEON REPLACED THE DEVICE WITH AN AR-2324BCC IMPLANT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY IN THE CASE OR ADDITIONAL ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590852 BIO-COMP SWVLK C, CLD 4.75X19.1MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP SWVLK C, CLD 4.75X19.1MM 15520622 00888867026827

    Patients

    Seq Age Sex Outcome Treatment
    1