BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEY F/PFNA BLADE

    MDR report key: 3193541 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03126
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    September 5, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    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. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE HISTORY RECORD REVIEW: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE ITEMS AT HAND ALL HAD DISCOLORATIONS WHICH WERE DOCUMENTED ON DIFFERENT AREAS OF ALL THE INSTRUMENTS. IRON OXIDE ON ALL RED-BROWN AREAS WAS DETECTED. THE CORROSION IS INITIATED ON THE WEAKEST AREAS THROUGH LONGER OPERATING TIMES AND/OR PREDOMINANTLY THROUGH THE PROCESSING OF THE INSTRUMENT. THE CHOSEN MANUFACTURE PROCESS IN COMBINATION WITH THE CHOSEN MATERIALS RESULTS IN LOCAL WEAK POINTS, PARTICULARLY WITH THE WRENCHES. FURTHERMORE, THE ORGANIC RESIDUES AND CLEANING MATERIAL RESIDUES WHICH WERE NOT REMOVED CORRECTLY LEAD TO AN AGGRESSIVE ATMOSPHERE AND CONTRIBUTE TO THE RECURRENCE OF CORROSION. NO NEGATIVE INFLUENCES IN TERMS OF THE MATERIAL QUALITY COULD BE DETECTED AMONG THE EXAMINED INSTRUMENTS. THERE ARE SLIGHTLY DARK DISCOLORED AREAS ON THE WHOLE SURFACE OF THE WRENCH; THIS MIGHT HAVE TO DO WITH CLEANING RESIDUES. ON THE SIDE AND IN THE PERFORATION THERE ARE RED-BROWN DISCOLORED AREAS NEXT TO THE CE-MARKING, IT COULD BE BLOOD, ORGANIC RESIDUES OR IRON OXIDE. THE EXAMINATION BY SCANNING ELECTRON MICROSCOPE (SEM) REVEALED A NETWORK STRUCTURE ON THE ENTIRE SURFACE. THIS FINISH QUALITY ON INSTRUMENTS WHICH WERE IN USE IS VERY TYPICAL FOR THE CHOSEN METHOD OF MANUFACTURE. THE OBSERVED NETWORK STRUCTURE CORRESPONDS TO THE GRAIN BOUNDARIES WHICH WERE ATTACKED BY THE MANUFACTURE AND FINALLY THE CORROSION MECHANISM. THE ENERGY DISPERSIVE X-RAY ANALYSIS (EDX) OF THE DIFFERENT RED-BROWN DISCOLORED AREAS SHOWED A CONTENT OF CARBON, OXYGEN, IRON AND CHROMIUM AS WELL AS A SMALLER CONTENT OF SILICONE, SODIUM, POTASSIUM AND CHLORINE.

    Description of Event or Problem · 1

    PFNA INSTRUMENTS DISPLAY RUST RESIDUE. THIS IS 4 OF 4 REPORTS FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294392 KEY F/PFNA BLADE KTT SYNTHES GMBH 2147969

    Patients

    Seq Age Sex Outcome Treatment
    1