BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAK DOUBLE LOADED FW CL

    MDR report key: 20214907 · Received September 13, 2024

    Report

    Report Number
    1220246-2024-07629
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 21, 2024
    Report Date
    February 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867206960
    PMA / PMN Number
    K181769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. TWO PACKAGED AND UNOPENED AR-3600-2 FIBERTAK¿ SUTURE ANCHOR WITH #2 FIBERWIRE BATCH NUMBER: 15211696 WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT DEVICE WAS DISCARDED BY THE FACILITY AND IS NOT AVAILABLE FOR RETURN. VISUAL EVALUATION OF THE PACKAGED DEVICES NOTED NO PROBLEMS. FURTHER VISUAL EVALUATION AFTER OPENING THE PACKAGING OF THE DEVICES ALSO DID NOT NOTE ANY PROBLEMS. FUNCTIONAL TESTING WAS PERFORMED BY TESTING THE MOVEMENT OF THE SUTURES WITHIN THE ANCHOR SHEATH. NO PROBLEMS WERE NOTED DURING TESTING, AS NO FRICTION OR RESISTANCE WAS NOTED. FURTHER FUNCTIONAL TESTING WAS PERFORMED USING A LABRUM MODEL. THE ANCHOR OF THE DEVICE WAS INSERTED INTO THE MODEL USING A KNOWN GOOD AR-3610F BATCH NUMBER: 0072229 AND A KNOWN GOOD MALLET. THE SUTURE WAS KNOTTED ONTO THE MODEL LABRUM WITH NO ISSUES. NO PROBLEM FOUND.

    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 A LATERJET CAPSULAR SUTURING THE SUTURE BROKE WHEN KNOTTED. 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 04-SEP 2024: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158122 FIBERTAK DOUBLE LOADED FW CL NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. FIBERTAK DOUBLE LOADED FW CL 15211696 00888867206960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown