BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE

    MDR report key: 1601365 · Received February 11, 2010

    Report

    Report Number
    1020279-2010-00041
    Event Type
    Injury
    Date Received
    February 11, 2010
    Date of Event
    November 6, 2009
    Report Date
    February 11, 2010
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV
    Product Code
    EKD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PULLED AND REVIEWED SHOP ORDER PAPERWORK. ALL PAPERWORK WAS COMPLETE AND CORRECT. COMPLETED SCAN OF ARTICULAR SURFACE OF PARTS, AND BOTH PARTS WERE ACCEPTABLE. COMPLETED DIMENSIONAL INSPECTION OF PART, AND ONLY CONCERN WAS THE SLOT ON THE TIBIA CUTTING BLOCK. IT WAS OVER TOLERANCE BY .006", AND THIS COULD BE DUE TO THE SURGEON CUTTING INTO THE PART WITH THE SAWBLADE; THE PAPERWORK SHOWED THAT AT FINAL INSPECTION, THE PART WAS ACCEPTABLE. ENGINEERING ALSO COMPLETED AN INVESTIGATION INTO THE COMPLAINT AND DETERMINED THAT THE ISSUES WERE DUE TO MRI IMAGE DISTORTION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT SURGERY TIME WAS EXTENDED DUE TO THE SURGEON HAVING ISSUES FITTING THE TIBIAL CUTTING BLOCK. THE COMPLAINT FOR THIS MDR WAS ORIGINALLY DETERMINED TO BE NOT REPORTABLE UNTIL UPDATED INFO FROM THE SALES REP MADE US AWARE THAT THE SURGERY TIME WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONAIRE TIBIAL CUTTING BLOCK / EKD EKD SMITH & NEPHEW, INC., ORTHOPAEDIC DIV NA PM003260-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization PART #V0100020, LOT# PM003260-1