BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER F/VISIOS+FRA TRIAL-IMPL

    MDR report key: 3173890 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03230
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    November 10, 2011
    Report Date
    November 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 ADDITIONAL EVALUATION REVEALED THAT THE THREAD PART OF THE INNER SHAFT IS BROKEN. THE THREAD PART IS STUCK INTO VISIOS TRIAL IMPLANT. NO MANUFACTURING RELATED CONDITIONS WERE FOUND AND WE HAVE TO ASSUME THAT THE INSTRUMENT WAS MOVED IN CRANIAL AND CAUDAL DIRECTIONS. THE DESIGN OF THE HOLDER FOR VISIOS WAS PLANNED FOR LATERAL MOVEMENTS TO REDUCE THE FORCES WHICH WERE CAUSED ON THE INNER SHAFT. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER PART OF 397.089 BROKE WHILE IT WAS BEING PLACED IN THE TRIAL IMPLANT 396.453. THE TIP OF THE INNER PART OF 397.089 IS NOW STUCK IN THE TRIAL IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274401 HOLDER F/VISIOS+FRA TRIAL-IMPL GDZ SYNTHES GMBH 3233260

    Patients

    Seq Age Sex Outcome Treatment
    1