BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-CORKSCREW FT, 5.5MM

    MDR report key: 1123764 · Received August 18, 2008

    Report

    Report Number
    1220246-2008-00158
    Event Type
    Other
    Date Received
    August 18, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THE PART/LOT COMBINATION. THE DEVICE HAS BEEN RECEIVED AND EVAL IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DELAY OF APPROXIMATELY FORTY FIVE MINUTES TO AN HOUR OCCURRED IN THIS SURGICAL CASE. THE SUTURE FIBERWIRE BROKE DURING TENSIONING ON THREE ATTEMPTS. THE SURGEON USED A KNOT PUSHER DURING THE FIRST ATTEMPT. THINKING MAYBE IT HAD A BURR, THE SURGEON DID NOT USE THE KNOT PUSHER A SECOND TIME. ON THE SECOND AND THIRD ATTEMPTS, THE SUTURE BROKE AGAIN WHEN SURGEON WAS JUST SLIGHTLY TYING THE KNOT WITH NO FORCE. THE SURGEON USED TWO PUSHLOCKS TO COMPLETE THE CASE. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP REQUESTS. NO ADDITIONAL 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 BIO-CORKSCREW FT, 5.5MM HWC ARTHREX, INC. NA 150932

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other