BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC ACETABULAR INSERTER

    MDR report key: 2033209 · Received March 17, 2011

    Report

    Report Number
    2033209
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BIOMET, INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED A LOANER TRAY FOR AN ORTHOPEDIC SURGERY. DURING THE PRE-SURGICAL INSPECTION CONDUCTED BY THE INSTRUMENT ROOM STAFF, IT WAS OBSERVED THAT THE WOOD HANDLE ON THE ACETABULAR SHELL INSERTER WAS BROKEN IN HALF (LENGTHWISE). THE MANUFACTURER WAS IMMEDIATELY CONTACTED FOR A REPLACEMENT WHICH WAS PROMPTLY RECEIVED. THE INSTRUMENT ROOM STAFF INDICATED THE "WOOD GETS FRAGILE." THE BROKEN INSTRUMENT WAS RETURNED (ALONG WITH THE LOANER TRAY AND REPLACEMENT INSTRUMENT) TO THE MANUFACTURER'S REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC ACETABULAR INSERTER INSERTER, ACETABULAR SHELL LXH BIOMET, INC 423609 592031

    Patients

    Seq Age Sex Outcome Treatment
    1 *