BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDINGBLOCK F/2-COLUMN DIST-RAD-PL2.4 6

    MDR report key: 3193518 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02930
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 22, 2011
    Report Date
    July 1, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE MEASURABLE DIMENSIONS OF THE BROKEN SET SCREW 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 DEVIATION REGARDING MATERIAL ANALYSIS STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARD. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHAT INDICATES MATERIAL CONFORMITY AS WELL. WE HAVE TO ASSUME THAT EXCEEDING APPLIED MECHANICAL FORCE MAY HAVE CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    THE SET SCREW BROKE OFF DURING REMOVAL. THE SURGEON PUT THE GUIDING BLOCK ON THE PLATE AND TEMPORALLY FIX IT BY GETTING THROUGH K-WIRES AT THE DISTAL HOLE AND MIDDLE HOLE OF PLATE. THEN HE TRIED TO FIX THE PLATE WITH THE CORTEX SCREW OVER THE GUIDING BLOCK. SO HE TIGHTENED THE SCREW AGAIN OF THE GUIDING BLOCK WITH THE LIMITED TORQUE DRIVER, BUT IT IDLED (SEEMED TO BE TIGHTENED ENOUGH). AFTER INSERTING THE DISTAL SCREW, THE SURGEON TRIED TO LOOSENED SCREW OF GUIDING BLOCK TO REMOVE IT BUT IT WAS BROKEN AND HE LEFT IN PLATE HOLE. SURGEON REPLACED THIS PLATE WITH OTHER ONE. THIS IS 1 OF 3 REPORTS FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292268 GUIDINGBLOCK F/2-COLUMN DIST-RAD-PL2.4 6 FZX SYNTHES GMBH 09-4567

    Patients

    Seq Age Sex Outcome Treatment
    1