BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL REPAIR TIGHTROPE, WITH INTERNALBRACE

    MDR report key: 19110721 · Received April 15, 2024

    Report

    Report Number
    1220246-2024-02027
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    February 26, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867363656
    PMA / PMN Number
    K202581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-1588R-IB ACL REPAIR TIGHTROPE® WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE DEVICE NOTED THAT THE SUTURE THREADER WAS NOT RETURNED. IT WAS FURTHER NOTED THAT THE WHITE LOOP SUTURE WAS BROKEN, THE LOOPS WERE DAMAGED AND TOWN, AND THE ENDS OF THE SUTURE WERE FRAYED. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED WHILE PASSING THE SUTURE WITH THE SUTURE THREADER. REFER TO INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE WHITE SUTURE OF THE DEVICE COULD NOT BE LOADED INTO THE LOOP TRAP. 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. UPDATE AVOE 02-APR-2024 IT WAS CONFIRMED THAT WHEN LOADING THE LOOP SYSTEM WITH THE WIRE LOOP, THE WIRE LOOP BROKE. UPDATE AVOE 04-APR-2024 THE FAILURE OCCURRED OUTSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892288 ACL REPAIR TIGHTROPE, WITH INTERNALBRACE NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. ACL REPAIR TIGHTROPE, WITH INTERNALBRACE 15126271 00888867363656

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown