BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.5 L16 SST

    MDR report key: 3192533 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03834
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    August 10, 2012
    Report Date
    August 14, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EVALUATION REVEALED THAT THERE IS INDEED A WRONG PART INSIDE. AS THE PACKAGE WAS ALREADY OPEN, WE ARE NOT ABLE TO VERIFY THE ORIGIN OF THE MISTAKE. ALL ARE DISTRIBUTED LONG TIME AGO AND WE ARE NOT AWARE OF ANY SUCH COMPLAINT. AS THERE SEEMS TO BE NO RISK OF ADDITIONAL FAULTY PARTS, WE DO NO INITIATE ANY FURTHER ACTIONS. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    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 02/15/2011. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW COMES IN THE WRONG PACKAGING. WHEN THE PACKAGE WAS OPENED THE DIAMETER WAS 2.0MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293782 CORTSCR Ø1.5 L16 SST HWC SYNTHES USA 2703546

    Patients

    Seq Age Sex Outcome Treatment
    1