BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM DI INTERMEDT CASTLE TIGHT

    MDR report key: 2962009 · Received February 14, 2013

    Report

    Report Number
    1526439-2013-12406
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED THAT THREE OF THE FOUR CASTLE NUT TABS HAD BEEN BROKEN OFF AT THE DISTAL TIP OF THE INSTRUMENT. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED DURING EVALUATION OF PRODUCT. HARDNESS VERIFICATION DETERMINED THAT THE MATERIAL WAS HEAT TREATED TO SPECIFICATION REQUIREMENTS. SCANNING ELECTRON MICROSCOPY ANALYSIS RESULTS CONCLUDED AN EVIDENT SHEAR STATIC FAILURE WHERE THE CRACK TERMINATION TOOK PLACE. FURTHERMORE, THE EXISTENCE OF THE TWO SURFACE MORPHOLOGIES ILLUSTRATED THAT THE FRACTURE FIRST PROPAGATED AND THEN A FULL FAILURE/BREAKAGE TOOK PLACE PRESUMABLY WHEN THE REMAINING REGION DID NOT HAVE STRENGTH TO BEAR THE LOAD. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. ALTHOUGH THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED, RESULTS CONCLUDED AN EVIDENT SHEAR STATIC FAILURE WHERE THE CRACK TERMINATION TOOK PLACE. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE TABS ON THE DISTAL END OF THE INTERMEDIATE TIGHTENER SNAPPED OFF DURING TIGHTENING OF THE OUTER SET SCREW. THE BROKEN TABS WERE REMOVED FROM THE SURGICAL SITE WITH A RESULTING TWENTY MINUTE DELAY TO THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65692 EXPEDIUM DI INTERMEDT CASTLE TIGHT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE NW116959

    Patients

    Seq Age Sex Outcome Treatment
    1