BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMOFIX TIB-HEAD-PL MED PROX 4HO TI

    MDR report key: 3222863 · Received July 12, 2013

    Report

    Report Number
    8030965-2013-04266
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K023941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WE HAVE SENT THE COMPLAINED PLATE AND SCREW TO THE RESPONSIBLE PRODUCT MANAGER FOR INVESTIGATION; HERE THE RESULT: THE LOCKING SCREW 413.338S IS BLOCKED IN TO THE TOMOFIX PLATE 440.834S. IT IS POSSIBLE THAT THE HEAD THREAD OF THE SCREW GOT COLD WELDED TOGETHER WITH THE PLATE HOLE. FURTHER IT COULD BE THAT PROTEIN PARTS ADHERED BETWEEN THOSE TWO ARTICLES AND MADE IT IMPOSSIBLE TO REMOVE THIS SCREW. REVIEWING THE MANUFACTURING- AND MATERIAL DOCUMENTATION OF THIS SCREW AND PLATE SHOWS CONFORMITY AS WELL. THE SCREW WAS MANUFACTURED IN NOVEMBER 2010. THE PLATE WAS MANUFACTURED IN JULY 2011. THE VARIOUS SCREWS ARE NOT DAMAGED. THEY ARE IN WORKING ORDER. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A HIGH TIBIAL OSTEOTOMY WAS CONDUCTED ON (B)(6) 2011. THE EXTRACTION WAS CONDUCTED ON (B)(6) 2013. THE SURGEON TRIED TO EXTRACT THE LOCKING SCREWS WITH A SCREWDRIVER, HOWEVER THE SECOND LOCKING SCREW REMOVAL FROM THE DISTAL END WAS DIFFICULT TO REMOVE. THE SURGEON CUT THE PLATE AND EXTRACTED THE HARDWARE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323033 TOMOFIX TIB-HEAD-PL MED PROX 4HO TI KTT SYNTHES GMBH 2750081

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR