BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE

    MDR report key: 5187837 · Received October 29, 2015

    Report

    Report Number
    1719045-2015-10703
    Event Type
    Injury
    Date Received
    October 29, 2015
    Report Date
    October 14, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 11 MARCH 2014. EXPIRATION DATE: 01 JANUARY 2023. PART: 04.004.443S, LOT: 7622615 (STERILE): NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. 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 A PATIENT HAD AN INFECTED NON-UNION OF THE DISTAL 1/3 SHAFT OF THE RIGHT TIBIA. THE ORIGINAL INJURY/DATE OF SURGERY WAS (B)(6) 2015 FOR AN OPEN FRACTURE. THE PATIENT WAS IMPLANTED WITH A NAIL, SCREWS, END CAP AND REVIVED A SKIN FLAP AT THE SURGICAL SITE AROUND THAT TIME AND IT WAS SUCCESSFUL. DURING THE REVISION ON (B)(6) 2015, HARDWARE WAS REMOVED INCLUDING AN INTACT NAIL, 3 INTACT SCREWS, 1 BROKEN SCREW AND AN INTACT 15MM END CAP. ALL HARDWARE WAS REMOVED SUCCESSFULLY. THE DOCTOR IMPLANTED AN ANTIBIOTIC ROD HE CREATED. NO FRAGMENTS OR BROKEN PARTS WERE LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND PATIENT STATUS WAS REPORTED AS FINE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718046 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES MONUMENT 7622615

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention