BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKX LOCKCAP F/498.571V TAV

    MDR report key: 3171097 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03327
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    March 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 IMPLANTS WERE RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE CLICK X LOCKING CAPS WERE BROKEN. THE IMPLANTS PRESENT SOME STRESS MARKS WHICH CAN BE ALLOCATED TO A MISALIGNMENT BETWEEN THE THREAD OF THE 3D-HEAD AND THE LOCKING CAP WHICH POPPED OFF. NO MANUFACTURING RELATED ISSUES WERE FOUND. 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. THE IMPLANTS PRESENT SOME STRESS MARKS WHICH CAN BE ALLOCATED TO A MISALIGNMENT BETWEEN THE THREAD OF THE 3D-HEAD AND THE LOCKING CAP WHICH POPPED OFF. THEREFORE, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND THE OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3D-HEAD FELL APART DURING TIGHTENING. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271660 CLICKX LOCKCAP F/498.571V TAV HWC SYNTHES GMBH 7677700

    Patients

    Seq Age Sex Outcome Treatment
    1