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 Codes	Blocked Connection (2888); Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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
It was reported that during a small surgery the dm was obstructed and the lens did not fit inside, therefore the device was unusable.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8850 centerline¿ endoscopic carpal tunnel release instrument, batch 5027156449, was received for investigation.Visual inspection noted chipping along both the outer and inner surfaces at the interface where the scope engages with the instrument.Functional testing was performed and it was observed that the scope would not properly align within the instrument.The cannulated shaft was found to be obstructed by a fragment.The most likely cause of the reported failure is attributed to misuse or mishandling of the device involving excessive force.The complaint allegation is confirmed.Refer to the attached investigation photographs for additional details.

• 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: 23389212
• Report Number: 1220246-2025-04817
• Device Sequence Number: 21335968
• Product Code: LXH
• UDI-Device Identifier: 00888867048546
• UDI-Public: (01)00888867048546(11)250301(17)300228(10)5027156449
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 5027156449
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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