MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV; ARTHROSCOPIC ACCESSORIES

Model Number	SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
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 surgery the patient experienced an involuntary arm movement which caused the ¿fish eye¿ end of the panoscope to come into contact with the sheath.This resulted in damage to both the scope and the sheath.Per complaint reporter there was no harm for patient, operator or third party.No further information received.

• Brand Name: SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 23631306
• Report Number: 1220246-2025-05162
• Device Sequence Number: 9382005
• Product Code: NBH
• UDI-Device Identifier: 00888867431270
• UDI-Public: 00888867431270
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 11/24/2025

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: SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV
• Device Catalogue Number: AR-3373-4202
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown