BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC/SOFAMOR DANEK

    MDR report key: 1363005 · Received April 15, 2009

    Report

    Report Number
    MW5010759
    Event Type
    Malfunction
    Date Received
    April 15, 2009
    Date of Event
    March 26, 2009
    Report Date
    April 7, 2009
    Manufacturer
    MEDTRONIC/SOFAMORE DANEK
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE CLEANING OF A PIN-DRIVER IN OUR SURGICAL SERVICES PROCESSING DEPT, THE DEVICE WAS BROKEN. FOREIGN MATERIAL WAS FOUND INSIDE THE INSTRUMENT. OUR MEDTRONIC REP WAS CONTACTED AND HE ENCOURAGED US TO BREAK ADDITIONAL DEVICES TO ASSESS IF THIS WAS A UNIQUE PROBLEM. FOREIGN MATERIAL WAS OBSERVED IN THE SLEEVE AND SHAFT OF THE ADDITIONAL BROKEN DEVICES. THE PRODUCT DESIGN DOES NOT ALLOW FOR ADEQUATE CLEANING OR STERILIZATION OF THIS DEVICE. THE DEVICE CANNOT BE DISASSEMBLED. WE DISCONTINUED USE OF THIS PRODUCT AS A PRECAUTIONARY STEP AND USE ALTERNATE INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC/SOFAMOR DANEK PLATE-HOLDING PIN DRIVER HXX MEDTRONIC/SOFAMORE DANEK 876-406
    2 MEDTRONIC/SOFAMOR DANEK PLATE-HOLDING PIN DRIVER HXX MEDTRONIC/SOFAMORE DANEK 9790903

    Patients

    Seq Age Sex Outcome Treatment
    1