BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGHTROPE ® II RT WITH DEPLOYING SUTURE

    MDR report key: 19174944 · Received April 24, 2024

    Report

    Report Number
    1220246-2024-02332
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 4, 2022
    Report Date
    April 24, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867319714
    PMA / PMN Number
    K231857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO USER-APPLIED MECHANICAL FORCES TO THE CONSTRUCT DURING USE.

    Description of Event or Problem · 0

    ON 3/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RT-2J TIGHTROPE II RT BUTTON WAS FLIPPED ON THE CORTEX AND THE TIGHTROPE WAS ADVANCED INTO THE TUNNEL WITH THE GRAFT. THE SURGEON PROCEEDED TO TENSION THE TIBIAL SIDE AND THE TIGHTROPE BECAME LOOSE, CAUSING THE GRAFT TO COMPLETELY COME OUT OF THE FEMORAL TUNNEL. THIS WAS DISCOVERED DURING A ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075862 TIGHTROPE ® II RT WITH DEPLOYING SUTURE NON-DEGRADABLE FIXATION FASTENER MBI ARTHREX, INC. TIGHTROPE ® II RT WITH DEPLOYING SUTURE 13633811 00888867319714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown