BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIRE GII FEMOR

    MDR report key: 3030117 · Received April 2, 2013

    Report

    Report Number
    1020279-2013-00191
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, THERE WAS INCONSISTENT TRANSITIONING OF THE ANTERIOR OSTEOPHYTE, IN SEVERAL SLICES OF THE MRI SCAN, WHICH SHOULD HAVE BEEN CORRECTED PRIOR TO MANUFACTURING THE FEMORAL CUTTING BLOCK. ALIGNMENT OF THE FEMORAL CUTTING BLOCK IS ACCEPTABLE PER SURGICAL PREFERENCES AND QUALITY ALIGNMENT STANDARDS. AS A RESULT OF THE INVESTIGATION, THE PRIMARY ROOT CAUSE OF THE ISSUE IS HUMAN ERROR DUE TO SEGMENTATION. THE INVESTIGATION ENGINEER REVIEWED THE COMPLAINT WITH THE DRAFTER/DESIGNER AND PRODUCT DEVELOPMENT ENGINEER RESPONSIBLE FOR PROCESSING THE CASE. THE DRAFTER/DESIGNER AND PRODUCT DEVELOPMENT ENGINEER RETRAINED ON THE SEGMENTATION STANDARD/ACCEPTANCE CRITERIA (B)(4). THE REGIONAL ENGINEER ACCOMMODATED THE SURGEON¿S REQUEST FOR BONE MODELS. THE ORIGINAL SEGMENTATION ALONG WITH THE CORRECTED SEGMENTATION ALONG WITH THE ORIGINAL BLOCK WAS SHIPPED FOR THE SURGEON TO REVIEW. ALL EMPLOYEES INVOLVED IN THE DESIGN, MANUFACTURING, AND INSPECTION OF THE QUALITY OF THE PRODUCT WERE INFORMED OF THE COMPLAINT. A CORRECTIVE AND PREVENTATIVE ACTION IS ONGOING FOR THIS FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED BETWEEN 30-60 MINUTES DUE THE O.R TEAM HAVING DIFFICULTY WITH THE CUTTING BLOCK FITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133989 VISIONAIRE GII FEMOR VISIONAIRE LT CUTTING BLOCK KIT-GII KDC SMITH & NEPHEW, INC. PM072486

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization