BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TIGHTROPE WITH FIBERTAG

    MDR report key: 19258754 · Received May 7, 2024

    Report

    Report Number
    1220246-2024-02879
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    February 23, 2022
    Report Date
    May 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867308459
    PMA / PMN Number
    K231857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. COMPLAINT CONFIRMED. ONE UNPACKAGED SP-05-01B BLUE SUTURE CONSTRUCT, ALONG WITH A C9015-01 TIGHTROPE AND ASSOCIATED C8827-01 BUTTON WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE C13484-02 FIBERLINK AND NEEDLE ASSEMBLY WERE NOT RETURNED FOR ANALYSIS. NO DAMAGE WAS PRESENT TO THE SP-05-01B BLUE SUTURE. IT WAS NOTED THAT THE C9015-01 TIGHTROPE HAD BROKEN INTO TWO PIECES, WITH REMNANTS IDENTIFIED WITHIN ONE OF THE BUTTON HOLES. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE BEING USED WHEN TENSIONING THE SUTURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A QUADRICEPS TENDON SURGERY THE SUTURES OF THE DEVICE TORE DURING INSERTION OF THE IMPLANT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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
    380963 ACL TIGHTROPE WITH FIBERTAG SMOOTH FIXATION PIN MBI ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG 14264800 00888867308459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown