BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE SHORT CUT PLATE CUTTER

    MDR report key: 3041689 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-10785
    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

    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 DEVICE IS IN GOOD CONDITION AND IS UNDAMAGED. THERE ARE SOME SMALL NICKS ON THE EDGES OF THE CUTTING SURFACE BUT WOULD NOT IMPACT THE ABILITY OF THE DEVICE TO FUNCTION PROPERLY. THE RETURNED DEVICE IS IN GOOD CONDITION AND IS FULLY FUNCTIONAL AND CAPABLE OF CUTTING PLATES AS DESIGNED. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID AS THERE IS NO ISSUE WITH THE RETURNED DEVICE.

    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 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144050 MATRIXMANDIBLE SHORT CUT PLATE CUTTER HTZ SYNTHES GMBH 3416296

    Patients

    Seq Age Sex Outcome Treatment
    1