BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER F/TEN

    MDR report key: 3181025 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03734
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    August 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. ACTUAL EVENT DATE NOT KNOWN. THE DEVICES WERE RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. OUR INVESTIGATION HAS SHOWN THAT THE COLLETS ARE JAMMED ON THESE COMPLAINED INSERTERS DUE TO A MECHANICAL OVERLOAD SITUATION. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE. 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. IT IS NOTED THAT WE HAVE JUST HARMONIZED TWO DESIGNS AND INCORPORATED THEM INTO A NEW ONE.

    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. DEVICE MANUFACTURE DATE WAS 11/07/2008. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES ARE JAMMED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280606 INSERTER F/TEN LXH SYNTHES GMBH 3028152

    Patients

    Seq Age Sex Outcome Treatment
    1