BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE

    MDR report key: 7735046 · Received July 31, 2018

    Report

    Report Number
    2939274-2018-53132
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    July 16, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982084491
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    THIS IS REPORT 2 OF 5 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT ETHNICITY IS UNKNOWN. DATE OF INFECTION AND NON-UNION IS UNKNOWN. DATE OF IMPLANTATION IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: NOVEMBER 26, 2014; EXPIRATION DATE: OCTOBER 2023; PART: 04.004.549S, LOT: 7860917 (STERILE) - 11MM TI CANNULATED TIBIAL NAIL - EX/345MM ¿ STERILE; LOT QUANTITY: 6. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS ACCEPTANCE SHEET, MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INSPECT DIMENSIONAL, MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG, WAS REVIEWED AND WAS FOUND TO BE CONFORMING: PACKAGING BOM FOR THIS LOT WAS REVIEWED AND FOUND TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN# (B)(4) STERILITY DOCUMENTATION SUPPLIED BY ETHICON ENDO-SURGERY WAS REVIEWED AND FOUND TO BE CONFORMING. NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING THE PRODUCTION OF THIS LOT. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF A TITANIUM (TI) CANNULATED TIBIAL NAIL-EXPERT WITH TWO (2) LOCKING SCREWS, AND A LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE WITH TWO (2) LOCKING SCREWS AND FOUR (4) CORTEX SCREWS DUE TO AN INFECTION OF NON-UNION. INFLAMMATION WITH PUS WAS NOTED IN THE MEDULLARY CANAL. THE IMPLANTATION DATE OF THE HARDWARE IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578956 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.004.549S 7860917 10886982084491

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention