BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TIGHTROPE RT

    MDR report key: 3192969 · Received June 27, 2013

    Report

    Report Number
    1220246-2013-00114
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    PMA / PMN Number
    K112990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINT EVALUATION REVEALED THAT THE WHITE SUTURE BROKE OFF AT THE SPLICE. BROKEN ENDS OF SUTURE ARE FRAYED. THIS TYPE OF EVENT IS TYPICALLY CAUSED BY NICKING THE SUTURE WITH ANOTHER INSTRUMENT, FRAYING FROM SHARP EDGES OF THE BONE TUNNEL AND/OR APPLYING EXCESSIVE FORCE WHEN SHORTENING THE SUTURE STRANDS. THE DIRECTIONS FOR USE (DFU-0147) FOR THE DEVICE STATES: "EXCESSIVE FORCE ON THE SHORTENING SUTURE STRANDS MAY BREAK THE STRANDS AND IMPAIR ABILITY TO FULLY SEAT THE IMPLANT." THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CINCHING THE TIBIAL BUTTON IMPLANT, DURING AN ACL RECONSTRUCTION, THE SUTURE BROKE NEAR THE BUTTON. THE FEMORAL IMPLANT WAS ALREADY IN PLACE, AS WAS THE GRAFT. BOTH THE FEMORAL AND THE TIBIAL BUTTONS WERE REMOVED ALONG WITH THE GRAFT. AN EXTENDED INCISION WAS USED IN THE EXISTING INSERTION POINTS TO RETRIEVE THE BUTTONS/GRAFT. THE GRAFT WAS REPOSITIONED AND THE CASE WAS COMPLETED USING A BTB TIGHTROPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293884 ACL TIGHTROPE RT PIN, FIXATION, SMOOTH HTY ARTHREX, INC. 815159

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other