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	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
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 10/30/2025, a sales representative reported via (b)(4) that an ar-8850 c-line soft tissue release instrument blade was slightly cutting the transverse ligament even when not deployed, which indicated that the blade may have been slightly "proud." this occurred during a case with no patient affected.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.The reported part was not returned for investigation.Instead, a sealed ar-8850 from batch 5189170320 was returned.Upon visual inspection of the centerline¿ endoscopic carpal tunnel release instrument did not reveal that the blade was assembled correctly, and no other visual issues were found.Functional testing was performed, with the ar-3350-2930/centerline carpal tunnel scope 30°, 2.9 mm x 158 mm, audible click sound, the blade activation worked as required.However, the reported part was not returned for investigation.No problem found.

• 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: 23567624
• Report Number: 1220246-2025-05077
• Device Sequence Number: 15933746
• Product Code: LXH
• UDI-Device Identifier: 00888867048546
• UDI-Public: (01)00888867048546(11)250801(17)300731(10)5189170320
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 5189170320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown