BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS

    MDR report key: 3242554 · Received May 30, 2013

    Report

    Report Number
    3242554
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BIOMET, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PROCEDURE WAS SCHEDULED THAT REQUIRED INSTRUMENTATION NOT MAINTAINED ON SITE. INSTRUMENTS ARE TO BE DELIVERED THOROUGHLY CLEANED, INSPECTED AND TESTED FOR PROPER FUNCTION. THESE INSTRUMENTS ARE NOT STERILIZED, HOWEVER, AND SO ARE DELIVERED TO THIS FACILITY A MINIMUM OF 12 HOURS PRIOR TO THE SCHEDULED PROCEDURE FOR THE CHECK-IN AND STERILIZATION PROCESS. DURING THE CHECK-IN PROCESS AND THE INITIAL INSPECTION OF INSTRUMENTATION, THE 9.0 MM REAMER WAS GROSSLY CONTAMINATED AND AN INSTRUMENT ON THE 150MM STS DISTAL TRIALS PAN WAS ALSO GROSSLY CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240116 ARCOS PROSTHESIS, HIP KWA BIOMET, INC. * *
    240117 ARCOS PROSTHESIS, HIP KWA BIOMET,INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *