BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TIGHTROPE

    MDR report key: 2103256 · Received May 26, 2011

    Report

    Report Number
    1220246-2011-00083
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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. DEVICE HISTORY RECORD NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. COMPLAINT CONFIRMED. VISUAL INSPECTION REVEALED THAT THE SUTURE LOOP APPEARS TO HAVE BEEN CUT AS WELL AS HAVING NICKS AND GOUGES ON THE LOOP. THE MOST LIKELY CAUSE(S) FOR TORN OR BROKEN SUTURES INCLUDE NICKING THE SUTURE WITH ANOTHER INSTRUMENT AND/OR FRAYING FROM SHARP EDGES OF THE BONE TUNNEL. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PULLED ACL TIGHTROPE UP INTO FEMORAL SOCKET, BUT PULLED TOO HARD AND THE BUTTON CAME OUT OF THE SKIN. THE SURGEON THEN MADE A SMALL INCISION ON THE OUTSIDE OF THE FEMUR (SKIN), AND TURNED THE BUTTON VERTICAL TO PUSH BACK DOWN TO BONE. THEN PULLED BACK ON THE GRAFT TO CONFIRM IT WAS SEATED AND THE GRAFT AND ACL TIGHTROPE CAME BACK OUT AND SAW THAT THE LOOP HAD BROKE. EVERYTHING WAS REMOVED AND STARTED OVER AGAIN WITH A NEW (B)(4), AND COMPLETED CASE WITH NO PROBLEMS

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other