BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL

    MDR report key: 5766040 · Received July 1, 2016

    Report

    Report Number
    3003875359-2016-10397
    Event Type
    Injury
    Date Received
    July 1, 2016
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HRS
    PMA / PMN Number
    PK141796
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT PROVIDED FOR REPORTING. DATE EVENT FIRST REPORTED WAS 20APR2016, UNKNOWN WHEN ACTUAL BREAKAGE OCCURRED. ORIGINAL IMPLANT DATE (B)(6) 2016. DATE RETURNED TO MANUFACTURER CONCOMITANT MEDICAL PRODUCTS: (15) CONCOMITANT DEVICES REPORTED. (B)(6). (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4) MANUFACTURING DATE: 13 NOVEMBER 2014, 440.831 / LOT: 9232106. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CLARIFICATION: THE MANUFACTURER WAS ORIGINALLY AWARE OF AN INCIDENT ON APRIL 20, 2016; HOWEVER, THIS PART¿S INVOLVEMENT IN THE EVENT WAS NOT KNOWN UNTIL JUNE 16, 2016. THEREFORE, DATE OF REPORT SHOULD REFLECT APRIL 20, 2016 AND DATE MFR RECEIVED (ON THE INITIAL MEDWATCH) SHOULD REFLECT JUNE 16, 2016. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: RECEIVED ONE TOMOFIX TIBIA PLATE PART 440.831. THE ARTICLE IS IN A USED CONDITION. THE IMPLANT PLATE IS BROKEN. NO NON-CONFORMANCES REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT. DURING MANUFACTURING INVESTIGATION ALL MEASUREMENTS OF THE ORIGINAL MEASURING DATA SET FROM OUR SUPPLIER WERE REVIEWED. THE MEASUREMENTS HAVE BEEN INSPECTED BY 100% AND ALL RECORDED VALUES ARE WITHIN SPECIFICATION. IMPORTANT FOR THE STRENGTH OF THE IMPLANT PLATE IS THE PLATE THICKNESS AND PLATE WIDTH. THE VALUES FOR BOTH MEASUREMENTS ARE WITHIN SPECIFICATION. FURTHER MEASUREMENTS WITH CMM (COORDINATE MEASURING MACHINE) COULD NOT BE TAKEN. REASONS ARE THAT IMPLANT PLATE IS BENT AND THAT ZERO POINT OF THE COORDINATE SYSTEM IS IN THE CENTER OF THE HOLE WHERE THE PLATE IS BROKEN. THEREFORE THE POSITIONS OF THE THREADED HOLES AND THE HEIGHT OF THE BALL SHAPED COUNTERSINK ARE NOT MEASURABLE ANYMORE. BOTH DAMAGES ARE CAUSED BY OVERLOADING AFTER IMPLANTATION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE BROKE POST-OPERATIVELY, BOTH LEFT AND RIGHT PLATES WERE BROKEN AT THE SAME TIME IN THE SAME PATIENT WHILE COMING DOWN FROM THE STAIRS. THE PLATE BROKE AT AN OCCUPIED SCREW HOLE. REVISION SURGERY HAS BEEN PERFORMED. PATIENT IS STABLE. ON 16 JUNE 2016: MATERIAL RECEIVED: 2 BROKEN PLATES AND ONE BROKEN SCREW. THIS COMPLAINT INVOLVES 3 PARTS. THE 440.831/ 9536288 / 1 / BROKEN PLATE - NON-REPORTABLE, 440.831 / 9232106 / 1 / BROKEN PLATE, 413.340 / 9651961 / 1 / BROKEN SCREW. CONCOMITANT PARTS: 413.328 / 9606999 / 1 / INTACT, 413.350 / 9701444 // 1 / INTACT, 413.336 / 9353941 / 1 / INTACT, 413.336 / 9636607 / 1 / INTACT, 413.355 / 9708150 / / 1 / INTACT, 413.350 / 9701444 / 1 / INTACT, 413.330 / 9680623 / 1 / INTACT, 413.334 / 9708946 / 1 / INTACT, 413.346 / 8916857 / 1 / INTACT, 413.330 / 9686051 / 1 / INTACT, 413.338 / 9662122 / 1 / INTACT, 413.346 / 8227378/ 1 / INTACT, 413.355 / 9708150 / 1 / INTACT, 413.342 / 8795886 / 1 / INTACT, 413.332 / 9678095 / 1 / INTACT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    CLARIFICATION: IT WAS FURTHER REPORTED THAT TWO (2) PLATES, BOTH LEFT AND RIGHT, AND ONE (1) SCREW BROKE POST-OPERATIVELY. IT WAS NOTED THAT THE PLATE BREAKAGE OCCURRED AT AN OCCUPIED SCREW HOLE. CLARIFICATION WAS ALSO RECEIVED AROUND THE REVISION/EXPLANT DATE, WHICH WAS ORIGINALLY REPORTED AS (B)(6)2016. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS CONFIRMED THAT THE REVISION WAS PERFORMED ON (B)(6) 2016. CONCOMITANT DEVICE(S) REPORTED: 5.0MM TI LOCKING SCREW (PART: 413.328 / LOT: 9606999 / QUANTITY: 1), 5.0MM TI LOCKING SCREW (PART: 413.350 / LOT: 9701444 / QUANTITY: 2), 5.0MM TI LOCKING SCREW (PART: 413.336 / LOTS: 9353941 AND 9636607/ QUANTITY: 1 OF EACH LOT), 5.0MM TI LOCKING SCREW (PART: 413.355 / LOT: 9708150 / QUANTITY: 2), 5.0MM TI LOCKING SCREW (PART: 413.330 / LOTS: 9680623 AND 9686051 / QUANTITY: 1 OF EACH), 5.0MM TI LOCKING SCREW (PART: 413.334 / LOT: 9708946 / QUANTITY: 1), 5.0MM TI LOCKING SCREW (PART: 413.346 / LOTS: 8916857 AND 8227378 / QUANTITY: 1 OF EACH), 5.0MM TI LOCKING SCREW (PART: 413.338 / LOT: 9662122 / QUANTITY: 1), 5.0MM TI LOCKING SCREW (PART: 413.342 / LOT: 8795886 / QUANTITY: 1), AND 5.0MM TI LOCKING SCREW (PART: 413.332 / LOT: 9678095 / QUANTITY: 1). THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419693 TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL PLATE, FIXATION, BONE HRS SYNTHES HAGENDORF 9232106

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 413.355, 5.0MM TI LOCKING HEAD SCREWSELF-TAPPING 5