BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW 20.1X21.4X4X0.6MM F/PIEZOELECTRIC SY

    MDR report key: 3193633 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02945
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    September 21, 2011
    Report Date
    October 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    PMA / PMN Number
    K100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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. ADDITIONAL PRODUCT CODES: ERL, HBE, HWE. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. ADDITIONAL EVALUATION RECEIVED THE PIEZO SAW BLADE BROKEN. THE MEASURABLE DIMENSIONS OF THE SAW BLADE WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATIONS. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. ADDITIONAL EVALUATION FOUND ONE OF THE TEETH WAS BROKEN, AS WELL AS THE UPPER EDGE APPEARS DAMAGED AS IF THE TIP HAS BEEN USED ON A HARDER MATERIAL-METAL. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THESE DAMAGES. NO PRODUCT FAULT COULD BE DETECTED THOUGH.

    Description of Event or Problem · 1

    PIEZO SAW BLADE BROKE DURING THE SURGERY. THE PATIENT'S BONE WAS VERY HARD AND THICK. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293216 SAW 20.1X21.4X4X0.6MM F/PIEZOELECTRIC SY DZI SYNTHES GMBH 601287/1

    Patients

    Seq Age Sex Outcome Treatment
    1