BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE SHORT CUT PLATE CUTTER

    MDR report key: 4230586 · Received November 6, 2014

    Report

    Report Number
    3003875359-2014-10358
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HTZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MATRIX-MANDIBLE SHORT CUT PLATE CUTTER BROKE DURING A PROCEDURE. THE SURGEON TRIED TO CUT THE PLATE AND ONE OF THE BLADES BROKE OFF THE CUTTER. THIS EVENT HAPPENED DURING AN ATTEMPT TO CUT A STERNAL CLOSURE PLATE WITH THE PLATE CUTTER. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH ANOTHER CUTTER. THERE WAS NO DELAY IN SURGERY AND THIS DID NOT AFFECT THE PATIENT. NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715086 MATRIXMANDIBLE SHORT CUT PLATE CUTTER INSTRUMENT, CUTTING ORTHOPEDIC HTZ SYNTHES HAGENDORF 1896314

    Patients

    Seq Age Sex Outcome Treatment
    1