BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3042113 · Received April 4, 2013

    Report

    Report Number
    3042113
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    February 15, 2013
    Report Date
    April 4, 2013
    Manufacturer
    *
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING A KNEE ARTHROSCOPY PROCEDURE THE TIP OF THE METAL TROCAR BROKE OFF IN THE JOINT. THE SURGEON WAS ABLE TO RETRIEVE THE PORTION THAT BROKE OFF AND COMPARE IT TO ANOTHER TROCAR TO MAKE SURE THERE WAS NO FOREIGN BODY LEFT IN THE PATIENT. ALL PIECES ACCOUNTED FOR. THE TROCAR WAS SENT BY SURGERY STAFF TO THE HOSPITAL'S CENTRAL STERILIZING DEPARTMENT WHERE IT WAS DISPOSED OF. NO MANUFACTURER INFO AVAILABLE, THE TROCAR IS USED FOR ARTHROSCOPIC KNEE PROCEDURES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?KNEE ARTHROSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137934 * GUIDE, SURGICAL, INSTRUMENT FZX * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR