BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3086911 · Received April 26, 2013

    Report

    Report Number
    3086911
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 26, 2013
    Manufacturer
    INNOMED, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SCREW HOLDING THE ROUND DISC OF AN INNOMED KNEE RETRACTOR SHEARED OFF DURING A CASE. THIS CAUSED A PORTION OF THE SCREW AND RETRACTOR TO COME OFF THE DEVICE. THE RETRACTOR WAS REMOVED FROM THE PATIENT'S KNEE AND ALL PIECES WERE ACCOUNTED FOR AT THE END OF THE CASE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RETRACTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182224 * RETRACTOR GAD INNOMED, INC. 1866 04101

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR PERHAPS OTHER INSTRUMENTS UTILIZED IN TOTAL KNEE| REPLACEMENT