BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE GII FEMOR

    MDR report key: 3831651 · Received May 26, 2014

    Report

    Report Number
    1020279-2014-00327
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO ISSUES. THE PRODUCT WAS NOT RETURNED; THEREFORE, NO DIMENSIONAL INSPECTION WAS COMPLETED. PER THE ENGINEERING INVESTIGATION, SEGMENTATION OF THE FEMUR IS UNACCEPTABLE PER QUALITY SEGMENTATION STANDARDS. THERE IS MISSED ANATOMY ON SLICE 9 AND SLICE 17 OF THE MRI. ON SLICE 17, A BIT OF ANTERIOR OSTEOPHYTE WAS NOT SEGMENTED; ON SLICE 9 THERE WAS A LITTLE BIT OF DISTAL ANTERIOR CORTICAL BONE/CARTILAGE UNSEGMENTED. BOTH MISSING AREAS OF ANATOMY WERE ONLY ON ONE SLICE BUT COULD CAUSE BLOCK FIT ISSUES. ALIGNMENT OF THE FEMUR IS ACCEPTABLE PER QUALITY ALIGNMENT STANDARDS AND SURGICAL PREFERENCES. AS A RESULT OF THE INVESTIGATION, THE PRIMARY ROOT CAUSE OF THE REPORTED ISSUE IS HUMAN ERROR DUE TO SEGMENTATION. CORRECTIVE ACTIONS FOR THE REPORTED ISSUE ARE BEING ADDRESSED UNDER VISIONAIRE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    POOR FIT OF FEMORAL CUTTING BLOCK NOTICED AFTER DISTAL RESECTION. FEMORAL CUTTING BLOCK FIT WELL ANTERIORLY AND LATERALLY. GAP OBSERVED BETWEEN MEDIAL PADDLE OF FEMORAL CUTTING BLOCK AND BONE. ALIGNMENT WAS ACCEPTABLE. ADDITIONAL NOTES: SURGEON TOOK AN ADDITIONAL 8MM OF DISTAL BONE AFTER RESECTING WITH FEMORAL CUTTING BLOCK. TIBIA BLOCK FIT WAS ACCEPTABLE AND A 9MM INSERT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309959 VISIONAIRE GII FEMOR VISIONAIRE DSTL FEM CUTTING BLOCK - GII KDC SMITH & NEPHEW, INC. PM107778V1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR