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	Sharp Edges (4013)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2025
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 06/17/2025, it was reported by a sales representative via sems-(b)(4) that an ar-3373-4202 sheath is sharp at the tip (fenestrated part).When going in and out of the patient, it is causing additional damage to tissue and cartilage.Discovered during a case and device swapped.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data arthrex concluded that the most likely cause of the reported failure was user error.This includes using a damaged device and/or making unintended contact between the instrument and other devices.The complaint allegation could not be confirmed, as the device was not returned for evaluation, and no supporting evidence of the reported failure was provided.

• 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: 22494282
• Report Number: 1220246-2025-02847
• Device Sequence Number: 4272532
• Product Code: NBH
• UDI-Device Identifier: 00888867431270
• UDI-Public: (01)00888867431270(11)250210(10)1818556
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/15/2025

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
• Device Lot Number: 1818556
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown