BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE SHORT CUT PLATE CUTTER

    MDR report key: 3031804 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10637
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT WAS RECEIVED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY IN PROGRESS

    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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS COMPLAINT IS INDETERMINATE. ORIGINAL AWARENESS DATE IS (B)(6) 2012. DEVICE HISTORY REVIEW WAS COMPLETED ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS BENDING PLATE AND THE PLATE CUTTER BROKE AT THE HEAD AND SNAPPED INTO TWO PIECES. ALL BROKEN FRAGMENTS WERE RETRIEVED. SURGEON USED ANOTHER PLATE CUTTER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THE PATIENT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133904 MATRIXMANDIBLE SHORT CUT PLATE CUTTER HTZ SYNTHES GMBH 1790796

    Patients

    Seq Age Sex Outcome Treatment
    1