BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIGHTROPE SYNDESMOSIS REPAIR KIT CANNULATED

    MDR report key: 1212764 · Received October 24, 2008

    Report

    Report Number
    1220246-2008-00202
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    PMA / PMN Number
    K000506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL, BUT WAS NOT RETURNED BECAUSE IT WAS DISCARDED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS THE TOGGLE (WHITE) SUTURE MAY HAVE BEEN PULLED OFF DURING INSERTION; IF THIS OCCURS, THE BUTTON CANNOT BE PASSED WITHOUT THE SUTURE AND A SECOND INCISION WOULD THEN BE NEEDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A LEFT ANKLE SYNDESMOSIS REPAIR, THE IMPLANT DID NOT HAVE A TOGGLE SUTURE TO SEAT THE OBLONG BUTTON. THE CASE WAS COMPLETED WITH ANOTHER VERSION OF THE DEVICE; A SECOND INCISION WAS NECESSARY TO HAVE BETTER ACCESS TO PLACE THE BUTTON PROPERLY (FLAT). FOLLOW-UP WITH THE REPORTER PROVIDED INFO THAT THE PATIENT'S QUALITY OF BONE WAS AVERAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REPORT STATED THIS WAS THE SURGEON'S FIRST TIME USING THE DEVICE. NO FURTHER PATIENT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIGHTROPE SYNDESMOSIS REPAIR KIT CANNULATED HTN ARTHREX, INC. NA 04031

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other INFO REQUESTED BUT NOT PROVIDED.