BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20248780 · Received September 18, 2024

    Report

    Report Number
    1220246-2024-07718
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867026827
    PMA / PMN Number
    K203495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS CONFIRMED UPON EVALUATION OF THE CUSTOMER ATTACHED PICTURE. PICTURE EVALUATION OF THE CUSTOMER'S ATTACHED PICTURE OF AN ALLEGED AR-2324BCC. IT REVEALED THAT THE BIO SCREW WAS DAMAGED AT THE PROXIMAL AND DISTAL ENDS MAKING THE IMPLANT LOSE GEOMETRY. IT WAS NOTED THAT THE MOLDED SWIVELOCK SHAFT'S TIP WAS WARPED A CLEAR INDICATION OF EXCESSIVE FORCES DURING INSERTION. THE MOST LIKELY CAUSES OF THE REPORTED FAILURE ARE IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND PRYING/LEVERAGING THE DEVICE DURING INSERTION. ACCORDING TODFU-0087 AT REVISION 3. G. PRECAUTIONS: 3. MAKE SURE TO USE THE RECOMMENDED DRILL BIT OR PUNCH TO CREATE THE BONE SOCKET. 4. PUSHLOCK AND SWIVELOCK SUTURE ANCHORS ONLY: DURING ANCHOR INSERTION, ENSURE THAT THE ANGLE OF ANCHOR INSERTION IS COAXIAL TO THAT OF THE PREVIOUSLY PREPARED BONE SOCKET. 5. PUSHLOCK AND SWIVELOCK SUTURE ANCHORS ONLY: INSERT THE DRIVER INTO THE BONE SOCKET UNTIL THE ANCHOR BODY MAKES CONTACT WITH THE BONE. PREVIEW AND ADJUST SUTURE TENSION, IF NECESSARY. TENSION WILL NOT INCREASE DURING FINAL ADVANCEMENT OF THE ANCHOR BODY. 6. PUSHLOCK AND SWIVELOCK SUTURE ANCHORS ONLY: ENSURE THAT THE ANCHOR BODY IS IN FULL CONTACT WITH THE BONE BEFORE ADVANCING THE ANCHOR BODY INTO THE PREPARED BONE SOCKET.

    Description of Event or Problem · 0

    ON 07/4/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL AR-2324BCC BIOCOMPOSITE SWIVELOCK SCREW CANNOT BE IMPLANTED WHEN THE KNOB IS TURNED. ADDITIONALLY, THE SHAFT WAS BENT. THE CASE WAS COMPLETED USING ANOTHER AR-2324BCC BIOCOMPOSITE SWIVELOCK. THIS WAS DISCOVERED DURING AN ANKLE INTERNAL BRACE PROCEDURE ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360813 BIO-COMP SWVLK C, CLD 4.75X19.1MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP SWVLK C, CLD 4.75X19.1MM 15205214 00888867026827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown