BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COIL W/CERCL-WIRE Ø1.25 L10M SST

    MDR report key: 3151179 · Received June 6, 2013

    Report

    Report Number
    8030965-2013-02747
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    April 13, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 IMPLANTS 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. WE CAN ONLY ASSUME THAT THE LABEL WAS NOT ADJUSTED ACCORDINGLY WHEN PACKAGING SWITCHED TO THE NEXT ARTICLE NUMBER. UNFORTUNATELY, THE ERROR WAS NOT DETECTED DURING QUALITY CONTROL PRIOR TO SHIPPING. THE LOT CONCERNED HAS BEEN SUBJECTED TO A DELIVERY STOP AND A CAPA DETERMINATION REQUEST HAS BEEN INITIATED. 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 THE PACKAGING 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 PACKAGE CONTENT DOES NOT MATCH THE DETAILS ON THE LABEL. 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
    249766 COIL W/CERCL-WIRE Ø1.25 L10M SST DZL SYNTHES GMBH 3156909

    Patients

    Seq Age Sex Outcome Treatment
    1