BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE SHORT CUT PLATE CUTTER

    MDR report key: 3041681 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-10784
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    September 29, 2011
    Report Date
    September 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE CUTTER WAS BROKEN INTO TWO PIECES WITH THE BREAK STARTING AT THE INTERIOR CORNER RADIUS OF THE SLOT. THE BREAK WAS ALIGNED WITH THE THROUGH HOLE FOR THE WIRE THAT HOLDS THE PLATES AFTER CUTTING. THE FRACTURE SURFACE IS HOMOGENOUS WITH NO SIGNS OF MATERIAL ISSUES. THE ONE WIRE THAT WAS FREED DURING THE BREAK WAS NOT RETURNED. PER EVALUATION DONE FOR A PREVIOUS COMPLAINT WITH THE SAME ISSUE, THE FRACTURE SURFACE OF THE CUTTER HEAD IS HOMOGENOUS AND DEMONSTRATES MINIMAL DUCTILITY WHICH IS CONSISTENT FOR THE S90V MATERIAL, A MARTENSITIC STAINLESS STEEL. THE FRACTURE PLANE RUNS THROUGH THE INTERIOR CORNER RADIUS WHICH IS THE FOCAL POINT OF THE HIGHEST STRESS CONCENTRATIONS DURING CUTTING. IT CAN BE INFERRED THAT THE APPLIED LOAD DURING CUTTING GENERATED A STRESS CONCENTRATION THAT EXCEEDED THE MAXIMUM ALLOWED STRESS AT THE INTERIOR CORNER RADIUS, RESULTING IN THE STATED BREAKAGE. FROM A DESIGN PERSPECTIVE THE COMPLAINT IS VALID. A DESIGN REVISION WAS COMPLETED UNDER DCO (B)(4) TO ADDRESS THE NOTED BREAKAGE WHICH WAS APPROVED ON (B)(4) 2010 AND BECAME EFFECTIVE INCLUDING AND AFTER PO (B)(4). THE DESIGN REVISION INCREASED THE ALLOWABLE STRESS OF THE PLATE UNDER THESE LOADING CONDITIONS BY ABOUT 49 PERCENT. BASED ON THE LOT NUMBER 3416296, THIS CUTTER WAS RECEIVED ON (B)(4) 2010, WHICH IS PRIOR TO DCO (B)(4). AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE, AND A DESIGN CHANGE HAS BEEN IMPLEMENTED. IT IS CONCLUDED THAT THIS COMPLAINT IS VALID.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF MANDIBLE FRACTURE THE SURGEON WAS USING THE MATRIX MANDIBLE SHORT CUT PLATE CUTTER TO CUT A PLATE IN HALF, AND THE PLATE CUTTERS BROKE. ALL THE PIECES WERE RETRIEVED. TWO MATRIX MANDIBLE SHORT PLATE CUTTERS WERE RECEIVED, BOTH SAME PART NUMBER AND LOT NUMBER. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143030 MATRIXMANDIBLE SHORT CUT PLATE CUTTER HTZ SYNTHES GMBH 3416296

    Patients

    Seq Age Sex Outcome Treatment
    1