BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE

    MDR report key: 12116488 · Received July 5, 2021

    Report

    Report Number
    2939274-2021-03401
    Event Type
    Injury
    Date Received
    July 5, 2021
    Report Date
    June 11, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982095244
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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 HISTORY LOT - PART # 04.034.449S, SYNTHES LOT # H813549, SUPPLIER LOT # NA, EXPIRATION DATE: 31 DEC 2027, RELEASE TO WAREHOUSE DATE: 21 JAN 2019. MANUFACTURED BY SYNTHES MONUMENT. NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW - REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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, PATIENT UNDERWENT A REVISION OF A TIBIAL SHAFT FRACTURE HYPERTROPHIC NON-UNION. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS AND REVISED. ALL IMPLANTS WERE INTACT UPON REMOVAL NOTHING WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DOING FINE POST-OPERATIVLELY. THERE WERE NO COMORBIDITIES FOR THE PATIENT. THE ORIGINAL DATE OF SURGERY WAS ON THE MONTH OF (B)(6) 2019. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013991 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.034.449S H813549 10886982095244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention