BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPDM DI INTERMEDT CASTLE TIGHT

    MDR report key: 2904152 · Received January 9, 2013

    Report

    Report Number
    1526439-2013-10639
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 9, 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 OF THE RETURNED INSTRUMENT 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 MET SPECIFICATION REQUIREMENTS. SCANNING ELECTRON MICROSCOPY ANALYSIS CONCLUDED AN EVIDENT SHEAR STATIC FAILURE WHERE THE CRACK TERMINATION TOOK PLACE. 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 DHR ACKNOWLEDGED THAT 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. THE ROOT CAUSE OF THE EVENT CANNOT BE POSITIVELY DETERMINED. A REVIEW OF PREVIOUS COMPLAINTS FOR ISSUES OF THIS NATURE REVEALED THAT AUSTRALIA HAS HAD A SIGNIFICANTLY HIGHER COMPLAINT RATE VERSUS THE U.S. AND O.U.S. WHICH SUGGESTS THAT THE AUSTRALIAN COMPLAINT RATE WAS DRIVEN BY A TECHNIQUE RELATED ISSUE. A CAPA HAS BEEN IMPLEMENTED TO DOCUMENT FURTHER INVESTIGATION AND CORRECTIVE ACTIVE ACTIVITIES. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    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 TWO TABS ON THE DISTAL END OF THE INTERMEDIATE CASTLE NUT TIGHTENER BROKE OFF INTRA-OPERATIVELY DURING CAP LOCKING. BOTH TABS WERE RETRIEVED FROM THE SITE WITHOUT DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12519 XPDM DI INTERMEDT CASTLE TIGHT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0609NT

    Patients

    Seq Age Sex Outcome Treatment
    1