BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/UTN

    MDR report key: 3142483 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02625
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    March 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 THREAD OF THIS CONNECTOR SCREW BROKE OFF DURING EXTRACTION AND REMOVAL. 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. ALSO, THE REVIEW OF RELEVANT RAW MATERIAL TEST CERTIFICATES DID NOT REVEAL ANY VARIATIONS IN MATERIAL ANALYSIS, TENSILE STRENGTH AND STRUCTURAL STABILITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE ITEM WAS MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. THERE IS NO PRODUCT ERROR. WE ARE UNABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM AND THE COMPLAINT CONDITION IS DUE TO THE CONDITION OF USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD OF THE SCREW BROKE OFF DURING SURGERY. 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
    244445 CONNECSCR F/UTN HWC SYNTHES GMBH 1935699

    Patients

    Seq Age Sex Outcome Treatment
    1