BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER-LARGE

    MDR report key: 3130933 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02871
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    June 17, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SUPPLIERS CERTIFICATIONS INDICATE THE CORRECT MATERIAL WAS USED AND CORRECT HARDNESS VALUES WERE OBTAINED. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE INVESTIGATION CARRIED OUT REVEALED THAT THAT THE SCREW OF THE GUIDE ARM HAS BROKEN OFF. WE SUSPECT THAT THE SCREW BROKE OFF DUE TO AN EXCESSIVE MECHANICAL LOAD AT THE TOP OF THE GUIDE BAR. DUE TO OTHER MESSAGES FROM THE MARKET, A CAPA DETERMINATION REQUEST HAS BEEN INITIATED IN ORDER TO FIND THE FAILURE CAUSE AND PROPOSE CORRECTIVE AND PREVENTIVE ACTIONS, INCLUDING A DESIGN CHANGE. THE DESIGN WAS AMPLIFIED AND THE SCREW AREA WAS REINFORCED. THIS DESIGN CHANGE WAS IMPLEMENTED AFTER THE RELEASE OF THE IMPLICATED DEVICE. THIS INSTRUMENT WAS MANUFACTURED IN 2005 AND STILL REFLECTS THE OLD VERSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PIVOT SCREW BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231487 INSERTER-LARGE MCV SYNTHES (USA) A7OA40

    Patients

    Seq Age Sex Outcome Treatment
    1