BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX W/O NDL. INTL

    MDR report key: 2000211 · Received February 18, 2011

    Report

    Report Number
    2648666-2011-00044
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 27, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    K912190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION, AS IT HAS BEEN DISCARDED. THE CLAIMED CONDITION AND THE ROOT CAUSE COULD NOT BE CONFIRMED. RISK DOCUMENTS WERE REVIEWED. ONE OF THE PROBABLE ROOT CAUSES FOR BROKEN EXTENSION TUBE ASSEMBLY IN THE JOINT CONNECTION WITH THE CEMENT INJECTION RESERVOIR IS: CEMENT SET-UP IDLE TIME EXCEEDED. EXCESSIVE INJECTION PRESSURE CAUSES FAILURE AT COMPONENT JUNCTIONS. DURING THE INVESTIGATION, IT WAS FOUND THAT THE CUSTOMER REFRIGERATED THE CEMENT POWDER AND THE LIQUID MONOMER. THE LIQUID MONOMER CAN BE REFRIGERATED TO EXTEND WORKING TIME, BUT NOT THE CEMENT POWDER. THIS ACTION CAN AFFECT THE MECHANICAL PROPERTIES OF THE CEMENT MIXTURE. THE MOST PROBABLE ROOT CAUSE IS USER RELATED.

    Description of Event or Problem · 1

    AFTER MIXING THE CEMENT FOR A VERTEBROPLASTY PROCEDURE, THE EXTENSION TUBE BROKE WHEN TRANSFERRING THE CEMENT INTO THE INJECTOR. THE CASE WAS EXTENDED FOR AN ADDITIONAL 45 MINUTES. THE PROCEDURE WAS ABLE TO BE COMPLETED USING ALTERNATE EQUIPMENT. THERE WAS NO ADVERSE CONSEQUENCE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPLEX W/O NDL. INTL MIXER-CEMENT JDZ STRYKER INSTRUMENTS PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK