BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SURGICAL INC

    MDR report key: 18543051 · Received January 19, 2024

    Report

    Report Number
    3007208013-2024-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 4, 2023
    Report Date
    January 19, 2024
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    HXK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SYMMETRY SURGICAL WAS MADE AWARE OF THIS COMPLAINT VIA A VOLUNTARY MEDWATCH REPORT FROM THE FDA. MW# MW5148935. THE REPORT DID NOT PROVIDE A PRODUCT CODE OR LOT NUMBER. WE ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION FROM THE USER FACILITY FOR COMPLAINT INVESTIGATION. IF ADDITIONAL INFORMATION IS OBTAINED OR INFORMATION THAT IS PERTINENT TO THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT A NEEDLE DRIVER BROKE WHILE IN USE. ALL PIECES WERE RETRIEVED. THE COMPLAINT WAS RECEIVED VIA VOLUNTARY MEDWATCH REPORT# MW5148935. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233475 SYMMETRY SURGICAL INC NEEDLE HOLDER HXK SYMMETRY SURGICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown