MAUDE Adverse Event Report: ARTHREX, INC. NANOSCOPIC RELEASE SYSTEM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	NANOSCOPIC RELEASE SYSTEM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 08/28/2025, it was reported by a sales representative via (b)(4) that an ar-8850ds nanoscopic release system dialator cut the distal portion of transverse ligament making the visual of the scope unworkable.This occurred during use in a case with no patient effect.The case was completed by converting to an open procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause of the reported issue is attributed to use-related factors, specifically unintended mechanical interaction between the ar-8850ds nanoscopic release system dilator and the transverse ligament during advancement, resulting in an unintended cut to the distal portion of the ligament and loss of visualization.

• Brand Name: NANOSCOPIC RELEASE SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23084741
• Report Number: 1220246-2025-03920
• Device Sequence Number: 10065021
• Product Code: LXH
• UDI-Device Identifier: 00888867390300
• UDI-Public: (01)00888867390300(11)220501(17)270430(10)5149160558
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: NANOSCOPIC RELEASE SYSTEM
• Device Catalogue Number: AR-8850DS
• Device Lot Number: 5149160558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown