BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT, NO NEEDLES

    MDR report key: 6423960 · Received March 22, 2017

    Report

    Report Number
    1526439-2017-10212
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 28, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NDN
    PMA / PMN Number
    K060300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE NEEDLELESS CONFIDENCE KIT (PRODUCT CODE: 2839-13-000, LOT NUMBER: 103635) WAS NOT RETURNED TO THE CUSTOMER QUALITY UNIT (CQU). WHILE IT WAS INITIALLY IDENTIFIED THAT THE KIT WAS AVAILABLE, THREE REQUESTS FOR ITS RETURN WERE MADE WITHOUT THE SAMPLE OR A TRACKING NUMBER BEING RETURNED. AS 34 DAYS HAVE PASSED WITHOUT EITHER BEING RECEIVED, THE STATUS OF THE SAMPLE HAS BEEN UPDATED TO ¿NONE.¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. WITHOUT THE KIT, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS REOPENED AFTER THE SAMPLES WERE RECEIVED ON MARCH 31ST, 2017. THE CEMENT EPOXY AMPOULE, MIXER, RESERVOIR CAP, AND RESERVOIR WERE RETURNED. THE CEMENT IN THE RESERVOIR APPEARS TO HAVE THICKENED DURING INSERTION INTO THE RESERVOIR. THE CEMENT IS NOT HOMOGENOUS AND HAS FLECKS OF WHITE DUST ON ITS SURFACE. LITTLE DIRECT INVESTIGATION CAN BE PERFORMED AS THE CEMENT HAS ALREADY SOLIDIFIED. THE CEMENT MAY HAVE SOLIDIFIED PREMATURELY DUE TO THE MANNER WITH WHICH IT WAS STORED AND OTHER ENVIRONMENTAL FACTORS THAT MIGHT HAVE AN IMPACT ON THE CEMENT¿S SETTING TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE CEMENT SETTING PREMATURELY CANNOT BE DETERMINED FROM THE SAMPLES AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE ENVIRONMENT FACTORS IN REGARDS TO THE STORAGE OF THE CEMENT. THE CONFIDENCE SPINAL CEMENT SYSTEM KIT¿S INSTRUCTIONS FOR USE (IFU-0902-90-055 REV. 7) STATES THAT THE CEMENT SHOULD BE STORED UNOPENED IN ITS ORIGINAL PACKAGING, IN A DRY, CLEAN PLACE AWAY FROM LIGHT, AT A MAXIMUM TEMPERATURE BETWEEN 41° F (5° C) AND 77° F (25° C). WORKING TIME AT OPERATING ROOM AND MATERIAL TEMPERATURE OF 20 DEGREES CELSIUS IS 9 MINUTES. THE HANDLING CHARACTERISTICS AND SETTING TIME CAN VARY IF THE PRODUCT HAS NOT BEEN FULLY EQUILIBRATED AT 68° F (20° C) BEFORE USE. THE UNOPENED PRODUCT SHOULD BE STORED AT 68° F (20° C) FOR A MINIMUM OF 24 HOURS BEFORE USE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DIRECTLY AFTER MIXING THE CEMENT HARDENED. IT WAS NOT POSSIBLE TO USE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205849 CONFIDENCE KIT, NO NEEDLES CEMENT / CEMENT ACCESSORY NDN DEPUY SYNTHES SPINE 103635

    Patients

    Seq Age Sex Outcome Treatment
    1