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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12-feb-2026, a facility representative reported via (b)(4) that the ar-8850 c-line soft tissue release instrument blade mechanism would not retract after initial deployment.No patient was harmed, and there was no procedural delay.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24520063
• Report Number: 1220246-2026-01255
• Device Sequence Number: 8430355
• Product Code: LXH
• UDI-Device Identifier: 00888867048546
• UDI-Public: 00888867048546
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 06/22/2026
• 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