BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOMED, INC.

    MDR report key: 17149394 · Received June 18, 2023

    Report

    Report Number
    1833053-2023-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2023
    Date of Event
    October 15, 2022
    Report Date
    July 18, 2023
    Manufacturer
    INNOMED, INC.
    Product Code
    GAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT # MW51133547 WAS RECEIVED AT INNOMED, INC. (INNOMED) FROM THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH WITH THE FOLLOWING EVENT DESCRIPTION DOCUMENTED "INOMED CANAL FINDER BROKE OFF IN PATIENT'S BONE. SURGEON WAS ABLE TO RETRIEVE INTACT TIP. NO HARM TO PATIENT." THE REPORT DID NOT IDENTIFY A CATALOG NUMBER OR AN INITIAL REPORTER TO CONTACT FOR RETURN OF THE DEVICE. THE INTERNAL COMPLAINTS DATABASE WAS SURVEYED FOR ALL ENTIES RELATING TO CANAL FINDERS AND THE DESCRIBED EVENT. NONE WERE FOUND. THE CAPA DATABASE WAS ALSO SURVEYED FOR THE SAME. NO ENTRIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    AS STATED IN THE PREVIOUS REPORT, A CATALOG NUMBER WAS IDENTIFIED, NOR AN INITIAL REPORTER IDENTIFIED TO CONTACT FOR RETURN OF THE DEVICE. INNOMED SURVEYED THE INTERNAL COMPLAINTS DATABASE WAS SURVEYED FOR ALL ENTRIES RELATING TO CANAL FINDERS AND THE DESCRIBED EVENT. NO ENTRIES WERE FOUND. THE CAPA DATABASE WAS ALSO SURVEYED FOR THE SAME. NO ENTRIES WERE FOUND. INNOMED DID NOT RECEIVE THE AFFECTED DEVICE IN FOR INSPECTIONAND EVALUATION.

    Description of Event or Problem · 0

    INNOMED CANAL FINDER BROKE OFF IN PATIENT'S BONE. SURGEON WAS ABLE TO RETRIEVE INTACT TIP. NO HARM TO PATIENT.

    Description of Event or Problem · 0

    INNOMED CANAL FINDER BROKE OFF IN PATIENT'S BONE. SURGEON WAS ABLE TO RETRIEVE THE INTACT TIP. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709510 INNOMED, INC. CANAL FINDER GAC INNOMED, INC.
    767400 INNOMED, INC. CANAL FINDER GAC INNOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown