BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY GORILLA/GORILLA PLATING SYSTEM

    MDR report key: 14027571 · Received April 6, 2022

    Report

    Report Number
    3008650117-2022-00033
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 7, 2022
    Report Date
    April 6, 2022
    Manufacturer
    PARAGON 28, INC
    Product Code
    HXI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A 1.6 K-WIRE BROKE DURING A PROCEDURE LEAVING A SLIVER IN THE PATIENT. THE SURGEON CHECKED THE SURFACE WHERE THE PIECE WAS LOCATED AND DECIDED TO LEAVE THE K-WIRE PIECE IN THE PATIENT AS IT WAS NOT PROMINENT AND NOT IN CONTACT WIHT ANY IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441963 BABY GORILLA/GORILLA PLATING SYSTEM K-WIRE, SINGLE ENDED TROCAR TIP, SMOOTH, 1.6 X 100 MM HXI PARAGON 28, INC P99-192-1610

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other