BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNSCR Ø7.3 SELF-DRILL L100/16 TAN GOLD

    MDR report key: 3171085 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03284
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 31, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 MICROSCOPIC INVESTIGATION SHOWS THAT THE IMPLANT WAS IN USE, AS THERE ARE HANDLING MARKS IN THE HEXAGON SOCKET AND ON THE HEAD. THE DIMENSIONS AND THE SHAPE MEET SPECIFICATIONS AND THE SHAPE DOES NOT SHOW ANY ANOMALIES. 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. NO PRODUCT FAULT COULD BE DETECTED AND THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. BASED ON THE INVESTIGATION RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WAS BROKEN AT THE TOP WHEN THE DEALER OPENED IT. 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
    271656 CANNSCR Ø7.3 SELF-DRILL L100/16 TAN GOLD HWC SYNTHES GMBH 2588468

    Patients

    Seq Age Sex Outcome Treatment
    1