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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-apr-2026, it was reported by a sales representative via (b)(4) that an ar-3373-4202 sheath is damaged, has a piece missing.Noticed during 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: d9, g3, h3, h6.Complaint allegation is confirmed.-visual evaluation revealed no visual damage to the sheath, hf, tap/fen, 2 stopcocks for pano¿ scope.-functional testing was performed, and the device was leaking from the black button.The most likely cause of the reported failure is misuse or mishandling, leading to damage to the black button and leakage.

• 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: 25042804
• Report Number: 1220246-2026-02566
• Device Sequence Number: 9580474
• Product Code: NBH
• UDI-Device Identifier: 00888867431270
• UDI-Public: (01)00888867431270(11)251030(10)1849104
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 05/22/2026

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: SHEATH,HI-FLOW,TAP/FEN,2STOPCOCKF/UWV
• Device Catalogue Number: AR-3373-4202
• Device Lot Number: 1849104
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown