BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TIGHTROPE

    MDR report key: 1904913 · Received November 22, 2010

    Report

    Report Number
    1220246-2010-00222
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTY
    PMA / PMN Number
    K100652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    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 REQUESTED FOR EVALUATION, BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS EVENT IS PULLING THE GRAFT UP WITHOUT TENSION. THE FOLLOWING INSTRUCTIONS ARE INCLUDED IN THE SURGICAL TECHNIQUE: "DO NOT PUT ANY TENSION ON THE TIGHTROPE, SHORTENING STRANDS UNTIL THE BUTTON HAS BEEN PASSED, AS THIS COULD COMPROMISE GRAFT ADVANCEMENT. IMPORTANT: PULL ON THE GRAFT FIRMLY TO CONFIRM FIXATION. RETENSION SHORTENING STRANDS IF NECESSARY." 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. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS TIGHTENING AND THE GRAFT WOULD RETRACT 5MM. THE SURGEON WOULD RE-TIGHTEN AND THE SAME THING WOULD HAPPENED; ALWAYS HAD THE SAME END POINT. HAD TO MAKE LATERAL INCISION TO TAKE OUT THE TIGHTROPE AND RE-DID THE GRAFT WITH A COMPETITOR'S DEVICE. ACL RECONSTRUCTION CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACL TIGHTROPE PIN, FIXATION, SMOOTH HTY ARTHREX, INC. 372436

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other