BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER INSTRUMENTS (FOR HIP) ASI TAPERLOC

    MDR report key: 2210234 · Received August 5, 2011

    Report

    Report Number
    2210234
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BIOMET
    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 SURGICAL INSTRUMENTATION (HIP-ASI TAPERLOC) THAT IS NOT MAINTAINED ON SITE. BIOMET IS TO DELIVER INSTRUMENTS THAT ARE THOROUGHLY CLEANED, INSPECTED AND TESTED FOR PROPER FUNCTION. THESE INSTRUMENTS ARE NOT STERILIZED. FOR THIS PARTICULAR CASE, THE INSTRUMENT TECHNICIAN INSPECTED THE TRAYS AS PART OF THE PRESURGICAL PREPARATION PROCESS AND FOUND MANY SOILED INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOANER INSTRUMENTS (FOR HIP) ASI TAPERLOC LOANER SURGICAL INSTRUMENTS KWA BIOMET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *