BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEG-WAY ECUTR

    MDR report key: 24228552 · Received January 30, 2026

    Report

    Report Number
    3010760216-2026-00001
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    July 7, 2025
    Report Date
    March 3, 2026
    Manufacturer
    TRICE MEDICAL, INC.
    Product Code
    LXH
    UDI-DI
    00857356008439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLETE DEVICE PART NUMBER WAS NOT REPORTED. THE REPORTED PART NUMBER IDENTIFIED THE GENERAL MODEL OF THE INSTRUMENT SET, BUT NOT THE SPECIFIC INSTRUMENT SET CONFIGURATION. A PART NUMBER FOR A SPECIFIC INSTRUMENT SET WAS ENTERED AS 200-5560-UCU ON THIS FORM 3500A BASED ON THE PROCEDURE REPORTED (CUBITAL TUNNEL RELEASE). IT IS POSSIBLE THAT A DIFFERENT INSTRUMENT SET CONFIGURATION WAS USED. NOTE: 08/14/2025 IS AN ESTIMATED DATE OF OCCURENCE, A DEFINITIVE DATE OF OCCURENCE WAS NOT SUPPLIED. THE INITIAL NOTIFICATION STATED THAT THE OPERATION TOOK PLACE "A FEW WEEKS AGO" FROM (B)(6) 2025. WE APOLOGIZE FOR THE DELAY IN SUBMITTING THIS REPORT. THERE WAS AN OVERSIGHT IN SCHEDULING THE REPORT PRIOR TO THE DUE DATE, COUPLED WITH DELAYS WITH THE ESG GATEWAY ACCOUNT. WE ARE TAKING MEASURES TO ENSURE BETTER TRACKING AND TIMELY REPORTING OF REPORTABLE EVENTS.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #01. SECTIONS A2, A3A, B3, B4, B5, G6, H2, H6 AND H11 HAVE BEEN UPDATED WITH NEW INFORMATION. FURTHER INFORMATION REGARDING THE DETAILS OF THE PROCEDURE AND THE PATIENT WAS PROVIDED BY THE INITIAL REPORTER WHICH HAS BEEN REFLECTED IN THE AFOREMENTIONED SECTIONS ABOVE. THE DESCRIPTION WAS AMENDED TO INCLUDE ADDTIONAL PROCEDURES FOLLOWING THE INITIAL EVENT AND THE STATUS OF THE PATIENT. ADDITIONALLY, A CORRECTION WAS MADE TO SECTION B3 AS THE PREVIOUS DATE DEPICTED WAS AN ESTIMATE, WHICH WE HAD MENTIONED IN THE INITIAL FORM 3500A SUBMISSION.

    Description of Event or Problem · 0

    DURING A CUBITAL TUNNEL RELEASE PROCEDURE WITH A SEG-WAY INSTRUMENT SET., THE PHYSICIAN REPORTED THE PATIENT'S ULNAR NERVE WAS SEVERED.

    Description of Event or Problem · 0

    DURING A CUBITAL TUNNEL RELEASE PROCEDURE WITH A SEG-WAY INSTRUMENT SET, THE PHYSICIAN REPORTED THE PATIENT'S ULNAR NERVE WAS SEVERED. THE PHYSICIAN TRANSECTED THE ULNAR NERVE ON PROXIMAL END OF THE CUT. THE PHYSICIAN THINKS THE GUIDE OPENED ON THE PROXIMAL END DUE TO TISSUE THICKNESS, OPENING UP THE END OF THE SHEATH. THE PHYSICIAN DID NOT SEE THE NERVE IN THE GUIDE. TWO ADDITIONAL PROCEDURES FOLLOWED THE INITIAL CUBITAL TUNNEL RELEASE PROCEDURE. THE PHYSICIAN RECONSTRUCTED WITH CADAVERIC ALLOGRAFT ON (B)(6) 2025, AND THEN PERFORMED A NERVE TRANSFER A FEW WEEKS LATER. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283418 SEG-WAY ECUTR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH TRICE MEDICAL, INC. 200-5560-ULCU NA 00857356008439

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Disability