BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED CURVED THORACIC PROBE ASSEMBLY

    MDR report key: 3142836 · Received June 3, 2013

    Report

    Report Number
    1526439-2013-18045
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION REVEALED THE PROBE¿S DISTAL TIP HAD BROKEN OFF FROM THE INSTRUMENT. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED DURING THE EVALUATION OF THE PRODUCT. THE INSTRUMENT WAS TESTED FOR HARDNESS AND MET SPECIFICATION REQUIREMENTS. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. REVIEW OF COMPLAINT DATA FOUND NO EMERGING TRENDS. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF INSTRUMENT BREAKAGE, RESULTS OF SCANNING ELECTRON MICROSCOPY ANALYSIS REVEALED EVIDENCE OF PLASTIC DEFORMATION AND ROUGH/GRAINY TEXTURE, INDICATING THAT THE PROBE UNDERWENT A STATIC BENDING FRACTURE FAILURE AT THE DISTAL TIP OF THE PROBE. 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. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    THE CURVED DISTAL END OF BROKE OFF FROM THE INSTRUMENT AND REMAINED IN THE PEDICLE FOR ABOUT 30 SECONDS. THE BROKEN SECTION WAS REMOVED FROM THE PEDICLE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244798 MODIFIED CURVED THORACIC PROBE ASSEMBLY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE BP017025

    Patients

    Seq Age Sex Outcome Treatment
    1