BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY HOOK, NERVE, TITANIUM HANDLE, 2 MM TIP, 7 1/4 INCH SHAFT

    MDR report key: 20445401 · Received October 14, 2024

    Report

    Report Number
    3007208013-2024-00054
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 19, 2024
    Report Date
    November 4, 2024
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SOME PICTURES HAVE BEEN PROVIDED. PRODUCT IS BEING SENT BACK FOR EVALUATION. WE DO NOT HAVE LOT INFORMATION YET BUT SHOULD BE ABLE TO GET THAT FROM THE DEVICE ONCE IT IS RETURNED. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER OF THE DEVICE AND PICTURES OF THE PROBLEMATIC DEVICE WERE NOT PROVIDED. BASED ON THIS, WE WERE VERY LIMITED IN OUR ABILITY TO INVESTIGATE. THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES "PART 80-1532 VERITY NERVE HOOK HAD THE BALL TIP BROKEN OFF INTO THE PATIENT. USED IN ACDF CASE. REQUIRED RETRIEVAL OF THE TIP, AND AN X-RAY TO CONFIRM ALL PIECES WERE RETRIEVED. NO HARM TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810608 VERITY HOOK, NERVE, TITANIUM HANDLE, 2 MM TIP, 7 1/4 INCH SHAFT SURGICAL HOOK GDG SYMMETRY SURGICAL INC. 80-1532 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown