BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SINGLE INNIE INSERTER

    MDR report key: 4090036 · Received September 15, 2014

    Report

    Report Number
    1526439-2014-11899
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 25, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: NOV-02-2011; JAN-03-2012. 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

    THE EXPEDIUM SINGLE INNIE X25 INSERTER WAS NOT RETURNED FOR EVALUATION. TWO PHOTOS OF THE DEVICE WERE PROVIDED AND THE COMPLAINT INVESTIGATION WAS BASED ON THE PROVIDED PHOTOS WHICH REVEAL THAT THE DISTAL TIP OF THE INSERTER FELL APART. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SINGLE INNIE X25 INSERTER FOUND NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE PRODUCT CODE FOUND NO EMERGING TRENDS. THE ROOT CAUSE OF THE X25 INSERTER¿S DISTAL TIP FALLING APART CANNOT POSITIVELY BE DETERMINED AS THE INSTRUMENT WAS NOT RETURNED. THE ROOT CAUSE CANNOT BE DETERMINED BASED UPON EXAMINATION OF THE PROVIDED PHOTOS. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO SYSTEMIC TRENDS HAVE BEEN OBSERVED. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE DEVICE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE DEVICE WILL BE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT IS AVAILABLE FOR THE INVESTIGATION. 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.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT WHILE PERFORMING AN EXPEDIUM CASE AND DURING INSERTION THE SECOND SET SCREW, THE SURGEON NOTICED THAT THE TIP OF THE EXPEDIUM SINGLE INNIE INSERTER HAD SEPARATED FROM THE INSTRUMENT¿S SHAFT. THE SEPARATED TIP WAS RETRIEVED AND ANOTHER INSERTER WAS USED TO CONTINUE WITH THE PROCEDURE. THE LENGTH OF THE RESULTING DELAY IS UNKNOWN. THERE IS NO REPORT OF ANY ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570402 EXPEDIUM SINGLE INNIE INSERTER SCREWDRIVER HXX DEPUY SYNTHES SPINE G0110

    Patients

    Seq Age Sex Outcome Treatment
    1