BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS 135° 2HO L46 SST

    MDR report key: 3123401 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02310
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    February 7, 2011
    Report Date
    February 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE INVESTIGATION CARRIED OUT REVEALED THAT THE POSITIONING GROOVES OF BOTH SCREW HAVE BEEN WIDENED UP DUE TO INADEQUATE HANDLING. THE PLATE ITSELF IS IN PERFECT WORKING ORDER AND WAS FUNCTIONAL TESTED WITH ANOTHER SCREW. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. IN ORDER TO ENSURE A CORRECT LOAD TRANSFER AND TO PREVENT SUCH OCCURRENCE, IT IS VERY IMPORTANT TO HAVE AN APPROPRIATE CONNECTION BETWEEN THE PLATE SCREW AND THE CONNECTING SCREW, WHICH IS GUIDED THROUGH THE WRENCH. IT IS SUFFICIENT TO CHANGE TO THE OCTAGONAL COUPLING SYSTEM FOR THE ONE STEP INSERTION TECHNIQUE. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND THE COMPLAINT IS UNJUSTIFIED WITH AN INVALID DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY TWO SCREWS AND ONE PLATE MALFUNCTIONED. INITIALLY, THE SURGEON ATTEMPTED TO IMPLANT THE PLATE OVER THE FIRST LAG SCREW AND THE PLATE WOULD NOT SLIDE OVER THIS LAG SCREW. A SECOND LAG SCREW WAS OPENED AND THE PLATE WOULD NOT SLIDE OVER THIS LAG SCREW EITHER. THE SURGEON THEN REPLACED THE PLATE WITH A NEW PLATE AND AGAIN THIS PLATE WOULD NOT SLIDE OVER THE LAG SCREW. A THIRD LAG SCREW WAS OPENED AND THE NEW PLATE NOW SUCCESSFULLY SLID OVER THE NEW THIRD LAG SCREW AND WAS IMPLANTED. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225076 DHS 135° 2HO L46 SST KTT SYNTHES GMBH 2660377

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR