MAUDE Adverse Event Report: TRICE MEDICAL, INC. SEG-WAY ECUTR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	200-5560-ULCU
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
During a cubital tunnel release procedure with a seg-way instrument set., the physician reported the patient's ulnar nerve was severed.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: SEG-WAY ECUTR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TRICE MEDICAL, INC.; 40 general warren blvd.; suite 100; malvern PA 19355
• Manufacturer (Section G): TRICE MEDICAL, INC.; 40 general warren blvd.; suite 100; malvern PA 19355
• Manufacturer Contact: david vancelette ; 40 general warrenn blvd.; suite 100; malvern, PA 19355 ; 9492388220
• MDR Report Key: 24228552
• Report Number: 3010760216-2026-00001
• Device Sequence Number: 13066562
• Product Code: LXH
• UDI-Device Identifier: 00857356008439
• UDI-Public: (01)00857356008439
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 200-5560-ULCU
• Device Catalogue Number: T400-062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 31 YR
• Patient Sex: Male