BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER

    MDR report key: 4192956 · Received October 22, 2014

    Report

    Report Number
    1526439-2014-12021
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 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

    VISUAL INSPECTION OF THE EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER REVEALED THAT ALL FOUR CASTLE NUT TABS WERE FRACTURED AT THE DISTAL TIP OF THE INSTRUMENT. FRACTURE ANALYSIS FOUND EVIDENCE OF A STATIC OVERLOAD FAILURE WHICH IS CONSISTENT WITH THE DIRECTION OF TIGHTENING AND THE SHEAR FAILURE MODE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DHR IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. TRENDING WAS COMPLETED AND THE OBSERVED RATE IS WITHIN THE RATE SET FORTH BY THE DFMEA. AS A RESULT, NO FURTHER TRENDING ACTION WILL BE TAKEN AS A PART OF THIS COMPLAINT INVESTIGATION. ALTHOUGH THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED BASED ON THE INFORMATION PROVIDED OR THE RETURNED SAMPLE, FRACTURE ANALYSIS FOUND EVIDENCE OF A STATIC OVERLOAD FAILURE. 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 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.

    Additional Manufacturer Narrative · 1

    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 THE TEETH OF THE EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER BROKE OFF FROM THE INSTRUMENT WHILE TIGHTENING AN INNIE SCREW. ALL PIECES WERE RETRIEVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO RESULTING DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673669 EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0609NT

    Patients

    Seq Age Sex Outcome Treatment
    1