BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM

    MDR report key: 13560378 · Received February 18, 2022

    Report

    Report Number
    2939274-2022-00537
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    January 20, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    20886982180862
    PMA / PMN Number
    K971987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODE: JEY. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN SURGICAL PROCEDURE THE 1.6 K WIRE BROKE WHEN ATTEMPTING TO REMOVE. WIRE WAS LEFT IN BONE/ ONE WAS ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6277 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 292.71 20886982180862

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention