BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY HOOK, NERVE, 2.0 MM BLUNT TIP

    MDR report key: 20788101 · Received November 26, 2024

    Report

    Report Number
    3007208013-2024-00061
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    September 19, 2024
    Report Date
    November 26, 2024
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ONLY INFORMATION THAT WE RECEIVED FOR THIS INCIDENT WERE INCLUDED ON MW5160111. THE REPORTER WAS CONFIDENTIAL, SO WE ARE UNABLE TO CONTACT THEM TO ASK FOR THE DEVICE TO BE RETURNED, OBTAIN PICTURES, OR GET ADDITIONAL INFORMATION. BASED ON WHAT WAS REPORTED, THE INVESTIGATION WAS VERY LIMITED AND A ROOT CAUSE CANNOT BE ESTABLISHED. THIS SHOULD BE CONSIDERED THE FINAL REPORT, HOWEVER IF ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES "THE HOOK, VERITY, NERVE, TI HANDLE, 2.0 MM BLUNT TIP, SS SHAFT, 7 1/4 IN, PART # 80-1532 MADE BY ASPEN SURGICAL BROKE OFF IN THE PATIENT DURING SPINAL SURGERY. THE PIECE WAS RETRIEVED, SO THERE WAS NO PATIENT HARM, JUST A PRODUCT DEFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368659 VERITY HOOK, NERVE, 2.0 MM BLUNT TIP SURGICAL NERVE HOOK GDG SYMMETRY SURGICAL INC. 80-1532 932750

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female