BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV-CHUCK W/T-HANDLE

    MDR report key: 3193488 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03124
    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. (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. 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. THE MACROSCOPIC EXAMINATION OF THE UNIVERSAL CHUCK SHOWED LIGHT DAMAGES AND DEFORMATIONS OF THE HANDLE. ON THE CROSSBAR OF THE T-HANDLE THERE WERE SHINY AREAS WHICH WERE PROBABLY CAUSED THROUGH STRIKES. VARIOUS DISCOLORED AREAS WERE ALSO DETECTED ON THE CHUCK JAWS; IT MIGHT BE A CASE OF ORGANIC RESIDUES, SUCH AS BLOOD OR IRON OXIDE. THE CANNULATION OF THE UNIVERSAL CHUCK WAS EXAMINED WITH AN ENDOSCOPE; IN SOME AREAS DARK DISCOLORATIONS WITH AXIAL SCRATCHED WERE DETECTED. NO ABNORMALITIES WERE FOUND WITH THE SCANNING ELECTRON MICROSCOPE (SEM). NO PARTICLES COULD BE REMOVED FROM THE CANNULATION AND THAT IS WHY NO FURTHER EXAMINATION AND CHARACTERIZATION WAS POSSIBLE.

    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)(4). DEVICE HISTORY RECORD REVIEW: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    PFNA INSTRUMENTS DISPLAY RUST RESIDUE. THIS IS 2 OF 4 REPORTS FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294250 UNIV-CHUCK W/T-HANDLE KTT SYNTHES GMBH 1022128

    Patients

    Seq Age Sex Outcome Treatment
    1