BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGHTROPE® II RT, RECON IB¿

    MDR report key: 19180496 · Received April 25, 2024

    Report

    Report Number
    1220246-2024-02369
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    February 15, 2022
    Report Date
    April 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867291638
    PMA / PMN Number
    K231857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    ON 2/16/2022, IT WAS REPORTED BY SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RT-IB TIGHTROPE II RT INTERNAL BRACE FIBERTAPE WAS LOADED BACKWARDS ON THE PRE-ASSEMBLED TIGHTROPE 2 WITH INTERNAL BRACE. THIS PREVENTED THE BUTTON FROM FLIPPING. SURGEON TOOK BUTTON OUT OF JOINT, FIXED FIBER TAPE ORIENTATION AND THEN DEPLOYED THE BUTTON APPROPRIATELY. THIS WAS DISCOVERED DURING ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605984 TIGHTROPE® II RT, RECON IB¿ NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. TIGHTROPE® II RT, RECON IB¿ 14338598 00888867291638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown