BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY KARLIN

    MDR report key: 14349824 · Received May 10, 2022

    Report

    Report Number
    3007208013-2022-00018
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    August 5, 2021
    Report Date
    May 10, 2022
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    EMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REQUESTED ADDITIONAL DETAILS ON AN INITIAL INCIDENT, WE WERE MADE AWARE OF THIS PREVIOUS INCIDENT THAT HAD OCCURRED IN (B)(6) 2021 THERE WERE NO OTHER DETAILS ABLE TO BE PROVIDED. THE DEVICE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. WITHOUT THE DEVICE AND NO KNOWN LOT NUMBER, A TRUE INVESTIGATION CANNOT BE COMPLETED AND A ROOT CAUSE CANNOT BE DETERMINED. THERE HAS BEEN A TOTAL OF 5,029 BOXES OF 10 (50,290 BLADES) SOLD SINCE 2012 WITH 8 ADDITIONAL COMPLAINTS OVER 12 BLADES. (0.02%). PER THE PRODUCT IFU, THIS DEVICE IS VERY DIFFICULT AND EXCESSIVE STRESS OR SIDEWAYS PRESSURE CAN CAUSE DAMAGE TO THE BLADE. BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE TINY TIP BROKE OFF IN THE INCISION. A CLOSING X-RAY WAS OBTAINED FOLLOWED BY AN INTERNAL INCIDENT REPORT. THERE WAS NOT ANY KNOWN POTENTIAL HARM TO THE PATIENT. THE SMALL FRAGMENT THAT BROKE WAS NOT FOUND ON THE X-RAY AND WAS NEVER LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239524 SYMMETRY KARLIN BLADE EMF SYMMETRY SURGICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown