BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMOFIX TIB-HEAD-PL SM MED PROX SHAFT 4H

    MDR report key: 3173797 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-02733
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    July 8, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K100676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 DRIVER HOLE ON THE SCREW WAS BROKEN, AND HE LOCK SCREW IS JAMMED INTO THE PLATE STRONGLY. THE MEASURABLE DIMENSIONS OF THE COMPLAINED DEVICES WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. 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. THE INVESTIGATION OF THE COMPLAINED DEVICES SHOWS THAT THE LOCKING HEAD OF THE SCREW IS STRONGLY BLOCKED INSIDE THE THREADED WHOLE OF THE PLATE. THE THREADS ARE COMPLETE FRETTED TOGETHER. THE REASON FOR THIS PHENOMENON MAY BE DIFFERENT. PERHAPS THAT TOO MUCH APPLIED MECHANICAL FORCE WHILE TIGHTENING MAY HAVE CAUSED THE PROBLEM. ANOTHER POSSIBLE REASON COULD BE AN INSTABLE FRACTURE WHICH CAN LEAD TO MICRO MOVEMENT WHICH CAN CAUSE SUCH FRETTING AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REMOVAL OF A TOMOFIX PLATE, IT WAS NOTICED THAT THE DRIVER HOLE ON THE SCREW HEAD WAS BROKEN. THE DRIVER COULD NOT FUNCTION. THE DOCTOR USED THE REMOVAL SCREW AND TRIED TO REMOVE THE SCREW, BUT THE TIP OF THE REMOVAL SCREW WAS BROKEN. THE SURGEON THEN TURNED THE TOMOFIX ITSELF AND REMOVED IT. DURING THE IMPLANTATION OF THE TOMOFIX PLATE, THE SURGEON USED THE CORRECT TORQUE, SO IT IS KNOWN THAT THE SCREW WAS UNDER PROPER TORQUE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274115 TOMOFIX TIB-HEAD-PL SM MED PROX SHAFT 4H HRS SYNTHES GMBH 3031711

    Patients

    Seq Age Sex Outcome Treatment
    1