BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9614267 · Received January 21, 2020

    Report

    Report Number
    2939274-2020-00310
    Event Type
    Injury
    Date Received
    January 21, 2020
    Date of Event
    December 26, 2019
    Report Date
    December 26, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL PRO-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 AS NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY: 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. 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 ON (B)(6) 2019, DURING A REMOVAL OF K WIRE FROM A BONE DUE TO A TEMPORARY FIXATION, THE WIRE BROKE AND PART OF IT WAS LEFT IN TIBIA. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN EXTRACTION INSTRUMENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS 1 OF 1 FOR PC-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72396 1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 292.71 20886982180862

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention