BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITANIUM PALATAL EXPANDER

    MDR report key: 760026 · Received August 2, 2006

    Report

    Report Number
    2081322-2006-00001
    Event Type
    Malfunction
    Date Received
    August 2, 2006
    Date of Event
    June 23, 2006
    Report Date
    July 13, 2006
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    DYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: VISUAL EXAMINATION OF THE FAILED NITANIUM PALATAL EXPANDER SHOWED THAT THE ORTHOLOY ARM (WIRE) HAS BROKEN, WHERE IT COMES OUT OF THE END INSERT. FAILURE ANALYSIS USING A SCANNING ELECTRON MICROSCOPE (SEM) REVEALED MULTIPLE FRACTURE ORIGINS DUE TO LATERAL FLEXURE OF THE ORTHOLOY ARM. ROOT CAUSE ANALYSIS WAS PERFORMED BY REVIEWING THE (I) FAILURE ANALYSIS DATA (II) MATERIAL PHYSICAL PROPERTIES AND (III) PAST PERFORMANCE HISTORY OF THE DEVICE. IT WAS DETERMINED THAT THE MOST PROBABLE FAILURE CAUSE WAS DUE TO DECREASE IN THE ELONGATION AND DUCTILITY OF THE ORTHOLOY ARM AS-RECEIVED FROM THE VENDOR. TO REMEDY THIS SITUATION, THE FOLLOWING ACTIONS HAVE BEEN UNDERTAKEN: TWO PROOF-TESTING STEPS HAVE BEEN ADDED TO THE MANUFACTURING PROCESS TO ELIMINATE POTENTIALLY BRITTLE APPLIANCES. ENTIRE STOCK OF ORTHOLOY WIRES HAS BEEN ANNEALED TO INCREASE THE ELONGATION AND DUCTILITY. TENSILE STRENGTH AND ELONGATION SPECIFICATIONS FOR THE INCOMING ORTHOLOY WIRE HAS BEEN CHANGED AND THE SUPPLIER HAS BEEN NOTIFIED. WE HAVE BEEN MARKETING THESE APPLIANCES FOR OVER 10 YEARS. THE BREAKAGE RATE OF ORTHOLOY ARMS IS AN EVENT WITH A LOW RATE OF OCCURRENCE (LESS THAN 0.02%).

    Description of Event or Problem · 1

    A 101-764 NITANIUM PALATAL EXPANDER WAS RETURNED TO ORTHO ORGANIZERS FROM OUR FOREIGN DISTRIBUTOR WITH A NOTICE THAT THE DEVICE BROKE IN THE PATIENT'S MOUTH. ALL PIECES OF THE DEVICE WERE PRESENT AND ACCOUNTED FOR IN THE RETURNED PACKAGE, VERIFYING THE PATIENT DID NOT INGEST ANY PORTION OF THE BROKEN DEVICE. NO REQUIRED MEDICAL INTERVENTION OR ADVERSE IMPACT ON THE PATIENT'S HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITANIUM PALATAL EXPANDER ORTHODONTIC INTRAORAL DEVICE DYJ ORTHO ORGANIZERS, INC. 101-764 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *