BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BONE FUNNEL 8MM

    MDR report key: 3941004 · Received July 17, 2014

    Report

    Report Number
    1526439-2014-11690
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    (B)(4). THE CONCORDE BONE FUNNEL 8MM WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE FUNNEL HAD BROKEN AT THE WELD AT THE PROXIMAL END OF THE DEVICE. THIS COMPLAINT WAS INITIALLY REPORTED IN MEDWATCH MANUFACTURER REPORT NUMBER 1526439-2014-11690 HOWEVER IT WAS DETERMINED THAT THE FRACTURE AT THE WELD WOULD NOT POSE ANY POTENTIAL FOR ADVERSE EFFECTS TO THE PATIENT DUE TO THE SIZE OF THE FUNNEL AND THE LACK OF SMALL PARTS. AS DIRECTED IN THE INITIAL REPORT, THE INVESTIGATION RESULTS ARE BEING PROVIDED IN FOLLOW UP MEDWATCH MANUFACTURER REPORT NUMBER 1526439-2014-11690. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12 MONTH COMPLAINT TREND ANALYSIS FOR THE CONCORDE BONE FUNNEL 8MM [PRODUCT CODE: 2879-08-008, LOT NO: X1010] WAS CONDUCTED ON THE PRODUCT CODE, AS THERE ARE NO LIKE PRODUCTS. THIS ANALYSIS FOUND NO SYSTEMIC TRENDS THAT REQUIRE FURTHER ACTION. THE ROOT CAUSE FOR THE DEVICE BREAKING CANNOT BE POSITIVELY IDENTIFIED. HOWEVER, IT WAS MOST LIKELY DUE TO UNANTICIPATED FORCES PLACED ON IT DURING SURGERY. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AT THIS POINT AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE, AND THERE HAVE BEEN NO SYSTEMATIC TREND. THEREFORE, THIS COMPLAINT 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

    INTERNATIONAL AFFILIATE REPORTS THE SURGEON WAS PACKING THE ALLOGRAFT BONE IN THE FUNNEL AT THE SURGICAL SITE AND THE NECK OF THE FUNNEL BROKE OFF THE STEM OF THE INSTRUMENT. USED SAME LIKE PRODUCT TO COMPLETE SURGERY. THE RESULTING DELAY WAS ABOUT FIVE MINUTES AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419533 CONCORDE BONE FUNNEL 8MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE X1010

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR