BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL TIGHTROPE WITH FIBERTAG

    MDR report key: 18420601 · Received December 29, 2023

    Report

    Report Number
    1220246-2023-09783
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    June 22, 2022
    Report Date
    December 29, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    UDI-DI
    00888867308459
    PMA / PMN Number
    K112990
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; NO PICTURES WERE PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING/TENSIONING; HOWEVER, DUE TO THE DEVICE NOT BEING RETURNED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUTURE OF THE DEVICE IS TORN AND THEREFORE THE DEVICE COULDN'T BE USED ON THE GRAFT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 23-JUN-2022. IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A SURGERY. THE SURGEON BEGAN TO STITCH THE FIBERTAG ON THE QUAD TENDON. AFTER THE SECOND WHIPSTITCH, HE NOTICED THAT THE FIBERTAG WAS TORN. HE REMOVED THE FIBERTAG FROM THE TENDON AND PUT IN A NEW ONE. UPDATE AVOE 30-JUN-2022. IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY. 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
    2285537 ACL TIGHTROPE WITH FIBERTAG SMOOTH FIXATION PIN HTY ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG 14448960 00888867308459

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown