BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY KARLIN

    MDR report key: 14220136 · Received April 27, 2022

    Report

    Report Number
    3007208013-2022-00010
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 27, 2022
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    GZT
    UDI-DI
    00887482015070
    PMA / PMN Number
    K882071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE RETURNED DEVICE, IT WAS CONFIRMED THAT THE BLADE HAD BROKEN INTO TWO PIECES. A TRUE ROOT CAUSE OF HOW THE DAMAGE OCCURED IS UNKNOWN. HOWEVER, WE CAN ASSUME THAT A SMALL CRACK HAD TO FORM IN THE MATERIAL AT SOME POINT PRIOR TO USE. THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY TWO YEARS BEFORE THE INCIDENT OCCURRED. THE MATERIAL AND HARDNESS OF THE DEVICE WERE CHECKED WITH ALL READING FOUND TO BE WITHIN CONFORMANCE PER THE PRODUCT SPECIFICATIONS AND INTENDED USE. THIS IS THE FIRST OCCURRENCE THAT WE HAVE RECEIVED FOR THIS OCCURRENCE. THEREFORE THIS IS AN ISOLATED EVENT. BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AND THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLAGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE RETRACTOR HAD BEEN IN PLACE FOR APPROXIMATELY 20 MINUTES IN THE PATIENT WHILE THE SURGEON WAS WORKING WITHOUT INCIDENT. THE SURGICAL STAFF WAS PREPARING TO DRAPE THE PATIENT AND BRINGIN O-ARM FOR IMAGING, WHEN THE RETRACTOR BLADE SUDDLENLY BROKE INTO TWO PIECES. WHEN THE BLADE BROKE IT EJECTED ITSELF OUT OF THE PATIENT ONTO THE FLOOR. THE PATIENT WAS CHECKED FOR FRAGMENTS FROM THE BREAK WITH NOTHING FOUND INSIDE THE PATIENT. THERE WAS NO FURTHER IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265670 SYMMETRY KARLIN RETRACTOR BLADE GZT SYMMETRY SURGICAL INC 46-3204 R002S283/98 00887482015070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown