BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 1784530 · Received July 8, 2010

    Report

    Report Number
    1784530
    Event Type
    Malfunction
    Date Received
    July 8, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 6, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    INSERTER THREADED MEDTRONIC 2980001 INSTRUMENT. INSTRUMENT DESCRIPTION; ONE ENDED OPEN LUMEN WITH INSERTER IN MIDDLE OF LUMEN, OTHER END CLOSED. MANUFACTURER'S INSTRUCTIONS ON CLEANING AND DECONTAMINATION DOES NOT SPECIFY ANY SPECIAL CLEANING INSTRUCTIONS FOR THIS INSTRUMENT.CENTRAL SUPPLY TECH NOTED DEBRIDE IN OPEN END LUMEN BUT WAS VERY DIFFICULT TO CLEAN DUE TO INSERTER IN MIDDLE. THEREFORE, AN ALLEN WRENCH WAS OBTAINED AND THE INSTRUMENT DISSASSEMBLED. ENTIRE INNER SURFACE WAS COATED WITH BLOOD AND DEBRIS. INSTRUMENT CLEANED AND REASSEMBLED. REASSEMBLY, HOWEVER, MAY NOT ALLOW A PRECISE FIT/REALIGNMENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DO NOT THINK DESIGN OF CERTAIN INSTRUMENT ALLOWS BREAK DOWN FOR PROPER DECONTAMINATION OF A PARTIAL CANNULATED INSTRUMENT. SPECIFIC INSTRUCTIONS ARE NOT GIVEN IN THE MANUFACTURER'S RECCOMENDATION. IN CONCLUSION, FEEL THAT ENGINEERED INSTRUMENTS DOES NOT ALLOW ACCEPTABLE DECONTAMINATION BETWEEN PATIENTS.====================== MANUFACTURER RESPONSE FOR IS A FUSION DEVICE INTENDED FOR STABILIZATION USE, CAPSTONE SPINAL SYSTEM======================CENTRAL STERILE CONTACTED MEDTRONIC REGARDING THE CLEANING. WE ARE ALSO HAVING PROBLEMS WITH OTHER MEDTRONIC DEVICES REGARDING THE CLEANING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM IMPLANT, SPINE, INSTRUMENT MAX MEDTRONIC SOFAMOR DANEK USA, INC CE 0123 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *