BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W

    MDR report key: 23378757 · Received October 24, 2025

    Report

    Report Number
    1220246-2025-04805
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 18, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867341890
    PMA / PMN Number
    K251809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, G3, H3, H6. THE COMPLAINT CANNOT BE CONFIRMED AS NO EVIDENCE OF THE FAILURE WAS RECEIVED. ONE UNPACKAGED AR-3632SP-1 BATCH 15395306 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED INSERTER REVEALED NO DAMAGE, SUCH AS A BENT SHAFT, A DETACHED SHAFT FROM THE HANDLE, OR BROKEN PARTS. FUNCTIONAL TESTING WAS PERFORMED BY GENTLY PULLING THE INSERTER AND CHECKING FOR ANY ISSUES. IT WAS NOTED THAT THE INSERTER IS PERFECTLY ATTACHED TO THE HANDLE AND NOT MOVING. NO PROBLEM FOUND WITH THE RETURNED DEVICE.

    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

    ***UPDATE, KHE, 28-OCT-2025. FURTHER INFORMATION RECEIVED WITH THE INCOMING DELIVERY DOCUMENT. IT WAS REPORTED THAT THE ANCHOR WAS TORN OUT DURING PLACEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SUTURE PULLED OUT AND DID NOT HOLD. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447063 SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W 15395306 00888867341890

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown