BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUSE CURETTE ANGLED

    MDR report key: 1880928 · Received October 4, 2010

    Report

    Report Number
    1044475-2010-00133
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 14, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JYG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: DHR REVIEW PERFORMED. RESULTS: DHR CONFIRMED THIS WAS AN ISOLATED INCIDENT. VISUAL EXAM REVEALED THE COMPLAINT WAS CONFIRMED. THE BREAK APPEARS TO SHOW THE DEVICE WAS OVER STRESSED. THE METAL LOOKS AS THOUGH IT WAS STRESSED AND BROKE OFF. THIS PRODUCT WAS MADE IN 2004. FUNCTIONAL TESTING SHOWED THAT A HARDNESS TEST REVEALED THE STEEL IS IN ACCEPTABLE RANGE. CONCLUSIONS: THIS IS MOST LIKELY A CASE OF THE PRODUCT FAILING AFTER ITS EXPECTED LIFE AND POSSIBLY WAS OVER STRESSED CAUSING THE PRODUCT TO FAIL AT ITS WEAKEST POINT. MFG DOES NOT APPEAR TO BE A ROOT CAUSE POSSIBILITY. NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHILE USING THE CURETTE, ONE TIP BROKE OFF. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUSE CURETTE ANGLED HOUSE CURETTE JYG TELEFLEX MEDICAL NA PP4

    Patients

    Seq Age Sex Outcome Treatment
    1