BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE TRITON 8MM GRAFT HARVEST

    MDR report key: 2798173 · Received October 22, 2012

    Report

    Report Number
    1625507-2012-00102
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    KFK
    PMA / PMN Number
    K870157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. VISUAL EXAMINATION OF AN EXAMPLE OF THE PACKAGING DETERMINED THAT THE DESCRIPTION, CONTAINING THE SIZE OF THE BLADE, WAS NOT REFLECTED ON THE CURRENT PACKAGING. GCAPA (B)(4) WAS OPENED ON (B)(6) 2012 TO ADDRESS THIS ISSUE. INSTRUCTIONS INCLUDED IN DEVICE USER MANUAL STATES, "PRIOR TO EACH USE, THE ENTIRE TRITON" POWER SURGICAL INSTRUMENT SYSTEM MUST BE INSPECTED FOR PROPER OPERATION". WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THERE WAS AN INCIDENT TODAY (B)(6) WHERE DOCTOR ASKED FOR A 8MM AND ENDED UP TAKING A 6MM GRAFT NOT KNOWING. I DO NOT KNOW THE EXTENT THE PACKAGING PLAYED ON THIS BUT I DO KNOW THERE WAS CONFUSION AND HE HAD TO TAKE A SECOND GRAFT." NO PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE UPON FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE TRITON 8MM GRAFT HARVEST SAW, POWERED, AND ACCESSORIES KFK MDT POWERED SURGICAL SOLUTIONS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other