BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TIGHTROPE RT

    MDR report key: 19477292 · Received June 6, 2024

    Report

    Report Number
    1220246-2024-05065
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    January 18, 2023
    Report Date
    June 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867019553
    PMA / PMN Number
    K231857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    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. UPON VISUAL EVALUATION, IT WAS NOTED THAT ONE SIDE OF THE SUTURE WAS TORN, THE OTHER SIDE SEEMS TO BE CUT AND FRAYED SUTURES WERE FOUND ON ONE SIDE OF THE EYE SPLICE. HOWEVER, BLUE SUTURE WAS NOT RETURNED FOR INVESTIGATION. 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 AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE RUPTURED AT THE BUTTON WHEN THE SURGEON RETRACED IT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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
    1980340 ACL TIGHTROPE RT SMOOTH FIXATION PIN MBI ARTHREX, INC. ACL TIGHTROPE RT 15004765 00888867019553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown