BEUDAMED
    FDA Adverse Event Summary report: N

    BIOMET LOANER TRAY INSTRUMENTATION TAPERLOC RPP PAN -

    MDR report key: 3766156 · Received April 10, 2014

    Report

    Report Number
    3766156
    Date Received
    April 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BIOMET, INC
    Product Code
    EKW
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LOANER SURGICAL TRAY INSTRUMENTS FOR SCHEDULED PROCEDURES ARE TO BE DELIVERED THOROUGHLY CLEANED, INSPECTED AND TESTED FOR PROPER FUNCTION. CONTAMINATED INSTRUMENTS WERE DISCOVERED AFTER PUTTING THROUGH WASHERS FOR A FINAL WASH. A SIGNIFICANT AMOUNT OF BIOBURDEN WAS DISCOVERED IN TWO TRIAL BROACHES (6.0 AND 9.0) IN PAN 4 OF 6 TAPERLOC RPP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219254 BIOMET LOANER TRAY INSTRUMENTATION TAPERLOC RPP PAN - BROACH EKW BIOMET, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *