BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGHTROPE® II ABS, IMPLANT OPEN

    MDR report key: 19568487 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06166
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    September 9, 2021
    Report Date
    June 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867371903
    PMA / PMN Number
    K241235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION.

    Description of Event or Problem · 0

    ON 9/10/2021 IT WAS REPORTED BY SALES REP VIA EMAIL THAT AN AR-1588TN-21 TIGHTROPE® II ABS, IMPLANT OPEN COULD NOT CINCH PROPERLY AS THE CRUTCH OF THE KNOT DID NOT APPEAR AS IT SHOULD BE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. ADDITIONAL INFO RECEIVED 9/13/2021. THIS WAS DISCOVERED DURING AN ACL REPAIR. SURGEON HAD TO USED OLD TIGHTROPES TO COMPLETE CASE. FACILITY DISCARDED DEVICES THEREFORE IT WILL NOT BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625599 TIGHTROPE® II ABS, IMPLANT OPEN NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. TIGHTROPE® II ABS, IMPLANT OPEN 12757787 00888867371903

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown