BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø3.5 L20 TI

    MDR report key: 3160775 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03287
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2012
    Report Date
    May 17, 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. 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. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE COMPLAINED IMPLANTS SHOWS THAT THERE REALLY WAS A PACKAGING ERROR WHERE THE WRONG SCREWS WERE PLACED IN THE PACKAGES. THERE WAS NO MISTAKE IN THE MANUFACTURING PROCESS. THE EMPLOYEE PICKED THE INCORRECT PRODUCTS FROM THE WAREHOUSE AND PUT THEM INTO THE PACKAGE BEING SENT TO (B)(6). THIS IS CLEARLY A HUMAN ERROR. THE PRODUCT IN QUESTION BEARS THE CORRECT LABEL FROM THE MANUFACTURING SITE AND WAS MISTAKENLY OVER-LABELED WITH THE (B)(4) LABEL. 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. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION: THE COMPLAINT IS VALID. BASED ON THE INVESTIGATION FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND IS DUE TO A HUMAN ERROR WHEREBY THE EMPLOYEE PICKED THE INCORRECT PRODUCTS FROM THE WAREHOUSE AND PUT THEM INTO THE PACKAGE BEING SENT TO (B)(6). A CAPA DETERMINATION REQUEST HAS BEEN INITIATED TO INVESTIGATE FURTHER THE ROOT CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WRONG PRODUCT WAS IN THE PACKAGING. 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
    262511 CORTSCR Ø3.5 L20 TI HWC SYNTHES (USA) 3783876

    Patients

    Seq Age Sex Outcome Treatment
    1