BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE SHORT CUT PLATE CUTTER

    MDR report key: 3083375 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11170
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 15, 2012
    Report Date
    August 31, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS THE PART WAS NOT RECEIVED.

    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). CORRECT MANUFACTURER INFORMATION IS SYNTHES (USA) , (B)(4). ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MANDIBLE RECONSTRUCTION PROCEDURE, AS THE SURGEON WAS CUTTING THE PLATE, THE INSTRUMENT BROKE; THE CIRCULAR END, THE CUTTING HEAD OF THE INSTRUMENT, CAME OFF THE HANDLE. ALL THE PIECES WERE RETRIEVED. THE SURGEON USED ANOTHER CUTTER TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT NOTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184965 MATRIXMANDIBLE SHORT CUT PLATE CUTTER HTZ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1