MAUDE Adverse Event Report: Arthrex, Inc. C-LINE ENDOSCOPIC SOFT TISS REL INST; ORTHOPEDIC MANUAL SURG INSTR

Model Number	C-LINE ENDOSCOPIC SOFT TISS REL INST
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 11-sep-2026, it was reported by a sales representative via email that an ar-8850 centerline device experienced intermittent "glitching" or "kicking" during a carpal tunnel procedure.It was further noted that the blade appeared to be slightly off kilter.The issue was described as the blade appearing to move to the left during device deployment and drawback, resulting in a distorted image and creating the impression that the blade was in an incorrect position.Troubleshooting included changing scopes, couplers, and centerline devices.No visible damage, misalignment, bending, or wear was observed.The procedure was completed as planned with no procedural delay, replacement device required, adverse event, patient injury, or device breakage.This was discovered during an unspecified carpal tunnel procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: C-LINE ENDOSCOPIC SOFT TISS REL INST
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50947643
• Report Number: 1220246-2026-04965
• Device Sequence Number: 10446292
• Product Code: LXH
• UDI-Device Identifier: 00888867048546
• UDI-Public: 00888867048546
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C-LINE ENDOSCOPIC SOFT TISS REL INST
• Device Catalogue Number: AR-8850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown