BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ SYRINGE KIT

    MDR report key: 3180675 · Received June 20, 2013

    Report

    Report Number
    2520274-2013-03628
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    August 4, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    NDN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE EVALUATION REVEALED THAT THE TWO RETURNED SYRINGE/CANNULA KITS SHOW THAT VARIOUS TIPS AND ADAPTERS HAVE ACTUALLY BROKEN OFF. UNFORTUNATELY WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS DAMAGE IN RETROSPECT. AS WE HAVE NOT RECEIVED ONE COMPLAINT OF THIS KIND (FOR BOTH KITS) FROM THE MARKET, WE PRESUME THAT THIS MUST BE AN ISOLATED INCIDENT.

    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. THE INITIAL MDR, MFR# 2520274-2013-03628, WAS FILED INCORRECTLY AS A 5-DAY REPORT. THE INITIAL MDR, MFR# 2520274-2013-03628, IS A 30-DAY REPORTABLE EVENT. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE ARE MULTIPLE BROKEN SYRINGES. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280782 VERTECEM V+ SYRINGE KIT NDN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1