BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGHTROPE ® II RT WITH DEPLOYING SUTURE

    MDR report key: 18579113 · Received January 25, 2024

    Report

    Report Number
    1220246-2024-00520
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    March 13, 2023
    Report Date
    January 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867319714
    PMA / PMN Number
    K231857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-1588RT-2J SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE FACT THAT THE DEVICE WAS RECEIVED DISASSEMBLED; ONLY THE SUTURE WAS RECEIVED, MISSING THE TIGHTROPE II BUTTON. VISUAL EVALUATION FOUND THAT THE WHITE SUTURE WAS BROKEN AND DETACHED FROM THE BUTTON. IT WAS NOTED THAT THE SUTURE WAS FRAYED. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED TO USE ERROR AS THE FRAYING CAN BE CAUSED BY PULLING OR ADJUSTING THE STRANDS ALONG A SHARP OR ROUGH EDGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY DURING INSERTION THE THREADS TORE. 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, 21-MAR-2023 FURTHER INFORMATION RECEIVED FROM THE CUSTOMER WITH THE DEVICE. THE THREAD BROKE DURING FLIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190565 TIGHTROPE ® II RT WITH DEPLOYING SUTURE NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. TIGHTROPE ® II RT WITH DEPLOYING SUTURE 15039033 00888867319714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown