BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE

    MDR report key: 6678818 · Received June 29, 2017

    Report

    Report Number
    1719045-2017-10613
    Event Type
    Injury
    Date Received
    June 29, 2017
    Report Date
    June 2, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT IDENTIFIER: (B)(6). PATIENT WEIGHT IS NOT AVAILABLE FOR REPORTING. (B)(4) DATE OF INFECTION AND INFLAMMATION DEVELOPMENT IS UNKNOWN. UDI: (B)(4). COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.034.552S, LOT# H123988. MANUFACTURING LOCATION: (B)(6), MANUFACTURING DATE: JUN 27, 2016, EXPIRY DATE: MAY 31, 2025. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. COMPONENTS REVIEWED: RAW MATERIAL PART 21012 LOT 9882215 WAS RECEIVED FROM (B)(6). CERTIFICATE OF REPORT AND RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. INSPECTION SHEET FOR IN-PROCESS ACCEPTANCE AND FINAL INSPECTION MEETS INSPECTION ACCEPTANCE CRITERIA. 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 POSTOPERATIVELY, ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT A PATIENT HAD PRESENTED WITH AN INFECTION AND INFLAMMATORY REACTION. THE PATIENT WAS IMPLANTED WITH A SYNTHES 11MM TITANIUM CANNULATED TIBIAL NAIL AND FIVE 5.0MM LOCKING SCREWS TO REPAIR A LEFT TIBIAL FRACTURE ON AN UNKNOWN DATE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2017 WHERE THEY UNDERWENT AN ASPIRATION PROCEDURE TO TREAT THE INFECTION AND INFLAMMATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THIS PROCEDURE. THIS REPORT ADDRESSES AN ASPIRATION PROCEDURE OF THE LEFT TIBIA DUE TO AN INFECTION AND INFLAMMATORY REACTION TO THE IMPLANTED DEVICES. REVISION SURGERY DUE TO NON-UNION HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 11MM TI CANN TIBIAL NAIL-EX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457852 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES MONUMENT H123988

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention