BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUSSCR Ø4 L60 SST

    MDR report key: 3151260 · Received June 7, 2013

    Report

    Report Number
    8030965-2013-02752
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    April 20, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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. 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 DEVICE SHOWS THAT THERE REALLY WAS A PACKAGING ERROR AND THAT THE PACKAGE CONTENT DOES NOT MATCH THE DETAILS ON THE LABEL. THIS IS CLEARLY A PACKAGING ERROR. ONE CYCLE DURING THE MANUFACTURING PROCESS WAS NOT CARRIED OUT AS INTENDED. THIS CONDITION WAS MISSED DURING THE FINAL INSPECTION. SINCE THIS WAS THE FIRST REPORTED EVENT CONCERNING THE ARTICLE AND LOT NUMBER IN QUESTION, WE CONSIDER THIS COMPLAINT TO BE AN ISOLATED EVENT. 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 DEFICIENCY IN THE QUALITY CONTROL PROCESS WHERE ONE CYCLE DURING THE MANUFACTURING PROCESS WAS NOT CARRIED OUT AS INTENDED. THIS CONDITION WAS MISSED AT FINAL INSPECTION AND THE PRODUCT WAS MISLABELED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WAS MISLABELED. 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
    252837 CANCELLOUSSCR Ø4 L60 SST HWC SYNTHES GMBH 2613708

    Patients

    Seq Age Sex Outcome Treatment
    1