BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6671324 · Received June 27, 2017

    Report

    Report Number
    1719045-2017-10603
    Event Type
    Injury
    Date Received
    June 27, 2017
    Report Date
    May 31, 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. DATE OF NONUNION DEVELOPMENT IS UNKNOWN. (B)(4). COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART #: 04.034.552S / LOT #: H123988 STERILE) - 11MM TI CANNULATED TIBIAL NAIL - EX W/PROX BEND 360MM-STERILE. QUANTITY 6: MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 27-JUN-2016, EXPIRATION DATE: 31-MAY-2025: COMPONENTS REVIEWED: RAW MATERIAL PART 21012 LOT 9882215 WAS RECEIVED FROM NF & M INTERNATIONAL/VSMPO-TIR. CERTIFICATE OF REPORT AND RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET SPECIFICATION. INSPECTION SHEET FOR IN-PROCESS ACCEPTANCE AND FINAL INSPECTION MEETS INSPECTION ACCEPTANCE CRITERIA. NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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 THAT POSTOPERATIVELY, IT WAS IDENTIFIED THAT A PATIENT HAD PRESENTED WITH A NONUNION. THE PATIENT WAS IMPLANTED WITH A SYNTHES 11MM TITANIUM CANNULATED TIBIAL NAIL AND FIVE 5.0MM LOCKING SCREWS TO REPAIR A TIBIAL FRACTURE ON AN UNKNOWN DATE. ON (B)(6), 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE DEVICES WERE EXPLANTED, ALL INTACT, AND A NEW NAIL AND TWO LOCKING SCREW WERE IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS REPORTED TO BE STABLE. THIS REPORT ADDRESSES REVISION SURGERY DUE TO NON-UNION. ON (B)(6) 2017 THE PATIENT UNDERWENT AN ASPIRATION PROCEDURE OF THE LEFT TIBIA DUE TO AN INFECTION AND INFLAMMATORY REACTION TO THE IMPLANTED DEVICES. THIS ISSUE HAS BEEN CAPTURED UNDER LINKED COMPLAINT COM-(B)(4). THIS REPORT IS FOR ONE (1) 11MM TI CANN TIBIAL NAIL-EX THIS IS REPORT 1 OF 2 FOR COMPLAINT COM-291033

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450364 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