BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER AFFINITI SHOULDER SURGICAL TRAY

    MDR report key: 1409406 · Received June 7, 2009

    Report

    Report Number
    1226487-2009-00002
    Event Type
    Malfunction
    Date Received
    June 7, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 7, 2009
    Manufacturer
    TORNIER, INC
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN ANTICIPATED. EVALUATION TO BE PERFORMED ON RECEIPT.

    Description of Event or Problem · 1

    NO PT INVOLVEMENT. IT IS REPORTED TO TORNIER, INC. THAT DURING A SALES PRESENTATION OF THE AFFINITI RELATED SURGICAL TOOLS TRAY, IT WAS DISCOVERED THAT A DRILL BIT WAS MISLABELED WITH THE IDENTIFICATIONS OF A LONGER DRILL BIT. THE SURGICAL TRAY AND THE INSTRUMENT CONTAINS ARE DURABLE, REUSABLE CLASS I DEVICES. DRILL BIT PART NUMBER 9000284 WAS MISLABELED IN SURGICAL TRAY 9000288.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER AFFINITI SHOULDER SURGICAL TRAY SURGICAL TRAY, ORTHOPEDIC LRP TORNIER, INC 9000288 AA1817

    Patients

    Seq Age Sex Outcome Treatment
    1