BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM

    MDR report key: 3223495 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04198
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    LRN
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL EVENT DATE NOT KNOWN. IMPLANT ON AN UNKNOWN DATE IN THE EARLY 1990S. THE INVESTIGATION COULD NOT BE COMPLETED AND A MANUFACTURING EVALUATION CAN NOT BE PERFORMED. NO CONCLUSION COULD BE DRAWN AS THE DEVICE IS NOT BEING RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED AN ANKLE FRACTURE ON AN UNKNOWN DATE. THE PATIENT WAS IMPLANTED WITH ONE-THIRD TUBULAR PLATE, K-WIRES AND SCREWS ON AN UNKNOWN DATE IN THE EARLY 1990S. A SYNDESMOTIC SCREW WAS PLACED IN THE ANKLE AND A POST-OPERATIVE X-RAY TAKEN ON AN UNSPECIFIED DATE REVEALED A HEALED FRACTURE BUT THE SYNDESMOTIC SCREW HAD BROKEN. REPORTEDLY THE PATIENT COMPLAINED OF PAIN. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF ALL HARDWARE. THE SURGEON REMOVED ALL HARDWARE EXCEPT FOR THE BROKEN FRAGMENT OF THE CANCELLOUS SCREW IN THE TIBIA. IT WAS REPORTED IT WAS DEEMED TOO INVASIVE TO ATTEMPT REMOVAL OF THE SYNDESMOTIC SCREW. THE IMPLANTS WERE REPORTEDLY REMOVED SUCCESSFULLY. THE HOSPITAL REPRESENTATIVE CERTIFIED THAT ALL THE INFORMATION AVAILABLE TO SYNTHES WAS PROVIDED AND THE HARDWARE WILL NOT BE RETURNED FOR EVALUATION. THE PART/LOT NUMBERS OF THE SCREWS ARE UNKNOWN. THE DATE OF EVENT IS ALSO UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321662 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM LRN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention