BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE LEGION FE

    MDR report key: 3053475 · Received April 11, 2013

    Report

    Report Number
    1020279-2013-00206
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO ISSUES. THE AFFECTED PRODUCT WAS NOT RETURNED. THEREFORE, NO DIMENSIONAL INSPECTION WAS COMPLETED. PER THE ENGINEERING INVESTIGATION, SEGMENTATION OF THE FEMUR AND TIBIA IS UNACCEPTABLE PER QUALITY STANDARDS. THERE WERE 6 MRI SLICES THAT CONTAINED UNCLEAR ANATOMY ON THE ANTERIOR FEMUR THAT WAS NOT INCLUDED IN THE 3D BONE MODEL. THE LATERAL PROXIMAL TIBIA PLATEAU CONTAINED 4 MRI SLICES WHERE THE CARTILAGE WAS NOT INCLUDED IN THE BONE MODEL. IT IS POSSIBLE THESE AREAS OF MISSED ANATOMY WERE RESPONSIBLE FOR THE INTRAOPERATIVE OBSERVATIONS OF NONCONFORMITY OF THE FEMUR AND TIBIA BLOCKS. ALIGNMENT OF THE FEMUR AND TIBIA IS ACCEPTABLE PER QUALITY STANDARDS. AS A RESULT OF THE INVESTIGATION, THE PRIMARY ROOT CAUSE OF THIS ISSUE IS HUMAN ERROR DUE TO SEGMENTATION. THE INVESTIGATION ENGINEER NOTIFIED THE PRODUCT DEVELOPMENT ENGINEER RESPONSIBLE FOR PROCESSING THE CASE OF THE REPORTED COMPLAINT. THE PRODUCT DEVELOPMENT ENGINEER AND DRAFTER/DESIGNER, RESPONSIBLE FOR PROCESSING THE CASE, REVIEWED THE SEGMENTATION ERRORS AND DOCUMENTED THOSE ERRORS ON THE SEGMENTATION QUALITY CHECK FORM. ALL ADDITIONAL EMPLOYEES INVOLVED IN THE DESIGN, MANUFACTURING, AND INSPECTION OF THE QUALITY OF THE PRODUCT WERE INFORMED OF THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OR STAFF HAD DIFFICULTY WITH THE BLOCKS FITTING AND SURGERY TIME WAS EXTENDED 30-60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154646 VISIONAIRE LEGION FE VISIONAIRE LT CUTTING BLOCK KIT - LGNP KDC SMITH & NEPHEW, INC. PM076147

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization