BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN

    MDR report key: 3173799 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-02735
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    September 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 ADDITIONAL EVALUATION REVEALED THAT THE COMPLETE UPPER PART OF ONE SHORTCUT PLATE CUTTER IS BROKEN OFF. BOTH BLADES CUTTING EDGES ARE BLUNT AND SHOW MARKS AND NICKS. THE MICROSCOPIC VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. EXCESSIVE FORCE CAUSED BREAKAGE. THE GENERAL GUIDELINES OF REPROCESSING CARE AND MAINTENANCE RECOMMEND CHECKING INSTRUMENT FOR SOUNDS SURFACES, CORRECT ADJUSTMENT AND FUNCTION. ALSO TO ARRANGE FOR ANY POORLY FUNCTIONING, DAMAGED, CORRODED OR BLUNT INSTRUMENTS TO BE REPAIRED OR REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPERATION A PAIR OF PLATE CUTTERS BROKE. THE CUTTERS BROKE IN TWO PIECES WHEN CUTTING A 2.0MM MATRIX-MANDIBLE PLATE. NO PIECES FELL INSIDE THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273331 SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN HTZ SYNTHES GMBH 1897591

    Patients

    Seq Age Sex Outcome Treatment
    1