BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE

    MDR report key: 3822971 · Received May 21, 2014

    Report

    Report Number
    2520274-2014-11552
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE: DATE PROVIDED AS ONLY 2013. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE PATIENT WAS IMPLANTED ON AN UNKNOWN DATE IN 2013 WITH A TIBIA NAIL AND 4 LOCKING SCREWS FOR TREATMENT OF A TIBIA FRACTURE. IT WAS REPORTED THAT THE PATIENT DEVELOPED PAIN AND A NON-UNION OF THE FRACTURE, AND 3 OF THE 4 SCREWS BROKE. PATIENT WAS RETURNED TO THE OPERATING ROOM, WHERE THE SURGEON SUCCESSFULLY REMOVED THE TIBIA NAIL AND SCREWS. THE NONUNION WAS REVISED TO A VARIABLE ANGLE LOCKING ANTEROLATERAL DISTAL TIBIA PLATE WITH LOCKING SCREWS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO EXTENSION OF TIME. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302110 8MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE NAIL, FIXATION BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention