BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRONT CUTTER

    MDR report key: 3142263 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02628
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE VISUAL INSPECTION OF THE FRONT CUTTER REVEALED THAT ONE OF THE CUTTING JAWS BROKE OFF AND THAT THE CUTTING FACES SHOWED SIGNS OF CONSIDERABLE WEAR AND TEAR. UNFORTUNATELY, THE COURSE OF EVENTS LEADING TO THE DAMAGE CANNOT BE ESTABLISHED WITHOUT FURTHER DETAILED INFORMATION. THE INSTRUMENT IN QUESTION IS ALREADY FOUR YEARS OLD AND HAS BEEN INTENSELY USED OVER AN EXTENDED PERIOD OF TIME. WE BELIEVE THAT SEVERAL INSTANCES OF EXCESSIVE STRESS OVER AND ABOVE THE LIMITS OF THE MATERIAL MAY HAVE LED TO BREAKAGE/FATIGUE. THE SURFACE ALONG THE BREAKAGE IS HOMOGENOUS INDICATING THAT THE MATERIAL QUALITY WAS FLAWLESS. INSPECTION IN ACCORDANCE WITH PRODUCTION AND MATERIAL DOCUMENTS INDICATED THAT THE HEAD CUTTER IS ENTIRELY COMPATIBLE WITH THE SPECIFICATIONS

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    CUTTING JAW OF CABLE CUTTER INSTRUMENT BROKE. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243210 FRONT CUTTER HXZ SYNTHES GMBH 1518878

    Patients

    Seq Age Sex Outcome Treatment
    1