BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE ADAPTION PLATE/6 HOLES/0.5MM THICK

    MDR report key: 4133198 · Received October 1, 2014

    Report

    Report Number
    3003506883-2014-10119
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    PK050608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME DZL. IT WAS REPORTED THE LOT NUMBER IS EITHER 9013351 OR 8885331 A DEVICE HISTORY REVIEW WAS COMPLETED ON BOTH LOTS AND ARE REPORTED BELOW FOR THE STERILIZED LOT NUMBERS FOR EACH. THE MANUFACTURING AND EXPIRATION DATES WERE ALSO DONE ON BOTH LOTS USING THE STERILIZATION LOT NUMBERS WITH THE FOLLOWING RESULTS: LOT 7499393, MANUFACTURING DATE: 10/9/2013, EXPIRATION DATE: 01 MAR 2024; LOT 7655992, MANUFACTURING DATE: 4/8/2014, EXPIRATION DATE: 01 JUN 2024. LOT 7499393 : A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TI MATRIX MIDFACE ADAPTION PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS ORDER WAS RELEASED TO THE WAREHOUSE ON (B)(4) 2013. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED IT TO CONFORM WITH ALL REQUIREMENTS AT THE TIME OF ACCEPTANCE WITH NO ANOMALIES NOTED. A DEVIATION (ED 357) WAS IN AFFECT AT THE TIME OF RECEIPT OF THIS MATERIAL THAT ALLOWED THE SHEET LENGTH TO BE UNDER THE SPECIFIED LENGTH SO THAT THE SUPPLIER COULD CONFORM TO THE MORE CRITICAL SPECIFICATION FOR FLATNESS. THIS DEVIATION HAS NO RELEVANCE TO THE COMPLAINT SINCE THE SHEETS ARE ULTIMATELY CUT INTO SMALLER BILLETS FOR USE IN OUR PROCESS. NO OTHER SPECIFICATIONS WERE CHANGED BY THIS DEVIATION, THEREFORE, THERE IS NO RELATIONSHIP TO THIS COMPLAINT LOT 7655992: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TI MATRIX MIDFACE ADAPTION PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS ORDER WAS RELEASED TO THE WAREHOUSE ON (B)(4) 2014. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED IT TO CONFORM WITH ALL REQUIREMENTS AT THE TIME OF ACCEPTANCE WITH NO ANOMALIES NOTED. A DEVIATION (ED 357) WAS IN AFFECT AT THE TIME OF RECEIPT OF THIS MATERIAL THAT ALLOWED THE SHEET LENGTH TO BE UNDER THE SPECIFIED LENGTH SO THAT THE SUPPLIER COULD CONFORM TO THE MORE CRITICAL SPECIFICATION FOR FLATNESS. THIS DEVIATION HAS NO RELEVANCE TO THE COMPLAINT SINCE THE SHEETS ARE ULTIMATELY CUT INTO SMALLER BILLETS FOR USE IN OUR PROCESS. NO OTHER SPECIFICATIONS WERE CHANGED BY THIS DEVIATION, THEREFORE, THERE IS NO RELATIONSHIP TO THIS COMPLAINT THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED WHEN ATTEMPTING TO BEND THE PLATE WITH 3D BENDING PLIERS DURING SURGERY, THE PLATE SNAPPED AND THERE-FORE THE PLATE COULDN'T BE USED. NO ADVERSE EFFECTS REPORTED TO PATIENT, AN ADDITION 1 TO 2 MINUTES WAS ADDED TO THE SURGERY THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611178 TI MATRIXMIDFACE ADAPTION PLATE/6 HOLES/0.5MM THICK PLATE, BONE JEY SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1