BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER

    MDR report key: 3841447 · Received May 30, 2014

    Report

    Report Number
    1526439-2014-11539
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    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

    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

    THE EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT ALL OF THE TABS AT THE DISTAL TIP OF THE DEVICE HAD BROKEN OFF. THIS WOULD CAUSE THE DEVICE TO NO LONGER ENGAGE THE CASTLE NUT AND THEREBY LET IT SPIN FREELY THEREFORE CONFIRMING THIS COMPLAINT. SCANNING ELECTRON MICROSCOPY (SEM) FOUND EVIDENCE OF PLASTIC DEFORMATION, ON EACH OF THE BROKEN TAB SURFACES, WHICH IS INDICATIVE OF A STATIC SHEAR FAILURE. ADDITIONALLY, THE PLASTICALLY DEFORMED MATERIAL IS CONSISTENT WITH THE DIRECTION OF TIGHTENING AND THE SHEAR FAILURE MODE. 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 REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER WAS CONDUCTED ON THE PRODUCT CODE, AS ANY CHANGE IN GEOMETRY WOULD CHANGE FORCES PLACED ON THE TIP OF THE DEVICE. THIS ANALYSIS FOUND NO EMERGING TRENDS. THE ROOT CAUSE FOR THE TIP BREAKING CANNOT BE POSITIVELY IDENTIFIED. HOWEVER, THE FRACTURED SURFACE EXHIBITS PLASTIC DEFORMATION INDICATIVE OF A STATIC SHEAR FAILURE. THE PLASTICALLY DEFORMED MATERIAL IS CONSISTENT WITH THE DIRECTION OF TIGHTENING AND THE SHEAR FAILURE MODE. 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 TABS ON THE DISTAL END OF THE EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER BROKE OFF FROM THE INSTRUMENT DURING USE. THE BROKEN TABS WERE RETRIEVED FROM THE SURGICAL SITE AND ANOTHER TIGHTENER WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318246 EXPEDIUM DI INTERMEDIATE CASTLE TIGHTENER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0210NT

    Patients

    Seq Age Sex Outcome Treatment
    1