BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW

    MDR report key: 6180667 · Received December 16, 2016

    Report

    Report Number
    0009613350-2016-01453
    Event Type
    Injury
    Date Received
    December 16, 2016
    Report Date
    November 17, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TREND ANALYSIS: NO TREND IDENTIFIED. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT INITIALLY HAD A ZNN NAIL BREAKAGE WHICH WAS REVISED ON (B)(6) 2016 (REPORTED UNDER (B)(4)). A NEW ZNN NAIL WAS IMPLANTED ON (B)(6) 2016. IN THE E-MAIL RECEIVED FROM THE PATIENT ON OCTOBER 29, 2016 IT STATES THAT THE PATIENT IS STILL GOING THROUGH A LOT. IN ANOTHER MAIL RECEIVED ON NOVEMBER 04, 2016 SHE IS DESCRIBING THAT 8 WEEKS AFTER THE NEW ZNN NAIL WAS IMPLANTED (ON (B)(6) 2016) SHE STILL HAVE 3 WEEKS TO GO WITHOUT PUTTING ANY WEIGHT ON HER LEG. A SPECIFIC EVENT DESCRIPTION WAS NOT PROVIDED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED FOR THE NEW ZNN NAIL WHICH WAS IMPLANTED ON (B)(6) 2016. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: THE REPORTED EVENT CANNOT BE RELATED TO A SPECIFIC FAILURE MODE. CONCLUSION SUMMARY: THE PATIENT INITIALLY HAD A ZNN NAIL BREAKAGE WHICH WAS REVISED ON (B)(6) 2016 AND A NEW ZNN NAIL WAS IMPLANTED. IN THE MAIL RECEIVED FROM THE PATIENT ON OCTOBER 29, 2016 IT STATES THAT THE PATIENT IS STILL GOING THROUGH A LOT. NO FURTHER INFORMATION RECEIVED ABOUT THE EVENT. NO DEVICES WERE RETURNED. NO FURTHER STATEMENT CAN BE DONE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW ON (B)(6) 2016 ON THE RIGHT SIDE AND IS EXPERIENCING AMBULATION DIFFICULTIES EIGHT WEEKS AFTER REVISION OF FEMORAL NAIL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. (SAME PATIENT IS TREATED IN (B)(4), REVISION DUE TO NAIL BREAKAGE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832769 ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS HSB ZIMMER GMBH N/A 2844483

    Patients

    Seq Age Sex Outcome Treatment
    1 Other