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	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/25/2025, it was reported by a sales representative via (b)(4) that an ar-8850 soft tissue instrument has a rough surface, not smooth.This occurred during use in a case with no patient effect.
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause of the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• 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: 23043177
• Report Number: 1220246-2025-03843
• Device Sequence Number: 15925154
• Product Code: LXH
• UDI-Device Identifier: 00888867048546
• UDI-Public: (01)00888867048546(11)250501(17)300430(10)5086158564
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 01/14/2026

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
• Device Lot Number: 5086158564
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown