BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20939521 · Received December 16, 2024

    Report

    Report Number
    1220246-2024-08881
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 19, 2024
    Report Date
    March 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K203495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION THAT THE ANCHOR IS TILTED IS CONFIRMED. ONE UNPACKAGED AR-2324BCC-1 BIOCOMPOSITE SWIVELOCK® C, 4.75 MM X 19.1 MM WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT THE ANCHOR WAS DAMAGED. IT WAS OBSERVED THAT THE ANCHOR WAS TILTED AND CRACKED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION. THE BONE QUALITY OF THE PATIENT AND THE INFORMATION OF THE INSTRUMENT USED TO PREPARE THE BONE SOCKET FOR INSERTION OF THE IMPLANT WERE NOT PROVIDED, THEREFORE IT CANNOT BE CONFIRMED THAT THE ANCHOR WAS INSERTED CORRECTLY. PER DFU-0087-EO REVISION 3, E. WARNINGS 6. BIOABSORBABLE ONLY: ATTEMPTING IMPLANTATION INTO HARD, DENSE BONE AND/OR DRILLING/PUNCHING SMALLER DIAMETER HOLES THAN RECOMMENDED MAY CAUSE FAILURE (BREAKAGE) OF THE IMPLANT DURING INSERTION.

    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

    IT WAS REPORTED THAT DURING AN RM-REK. SURGERY THE ANCHOR DID NOT HOLD INSIDE THE PATIENT EVEN THOUGH IT HAS BEEN INSERTED CORRECTLY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE, 13-DEC-2024 FURTHER INFORMATION RECEIVED WITH THE DEVICE. IT WAS REPORTED THAT THE ANCHOR WAS TILTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2382786 BIO-COMP SWVLK C, CLD 4.75X19.1MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP SWVLK C, CLD 4.75X19.1MM 15254508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown