BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE

    MDR report key: 7571636 · Received June 5, 2018

    Report

    Report Number
    2939274-2018-52416
    Event Type
    Injury
    Date Received
    June 5, 2018
    Report Date
    May 15, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982095398
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS 5¿11¿ (B)(6). DATE INFECTION AND NON-UNION BEGAN IS NOT KNOWN COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DHR REVIEW WAS COMPLETED. ITEM: 04.034.555S LOT: H213274 MFG QTY: 6 MFG LOCATION: (B)(4) MFG DATE: 21 OCT 2016 EXP DATE: 30 SEP 2025 SCN: (B)(4). THERE WERE NO NCS OR REWORKS IDENTIFIED IN THE DHR. PRODUCT WAS INSPECTED TO AND PASSED ALL REQUIREMENTS. DHR INDICATES PRODUCT WAS PACKAGED PER REQUIREMENTS. SCN FILE INDICATES PRODUCT WAS STERILIZED AT ETHICON ENDO-SURGERY USING THE GAMMA 25-40KGY METHOD. STERILIZATION RUN REPORT WAS PROVIDED BY ETHICON ENDO-SURGERY INDICATING THAT PRODUCT WAS PASSED WITH ALL DOSIMETERS IN RANGE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PATIENT WAS IMPLANTED WITH THE 11MM CANNULATED TIBIAL NAIL-EX AND SIX (6) 5.0MM LOCKING SCREWS ON (B)(6) 2017. ON UNKNOWN DATE, PATIENT PRESENTED WITH A FLASHED OPEN TIBIAL-FIBULAR FRACTURE FROM A MOTOR VEHICLE ACCIDENT, AS WELL AS AN INFECTION AND NON-UNION. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM CANNULATED TIBIAL NAIL-EX THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412351 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE NAIL,FIXATION,BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.034.555S H213274 10886982095398

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention