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	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-3373-4202 sheath, hf, tap/fen, 2 stopcock for pano¿ scope, batch 1849104 was received for evaluation.Visual inspection identified damage at the distal end of the instrument tip, including a large crack with bent edges.Additional bending was noted around the tip, along with scratches on the shaft near the tip.The reported failure and observed damage to the instrument were most likely caused by use error, which may include contact with another instrument during use, use as a prying tool, and/or impact with other instruments.Directions for use dfu-0073-eo revision 4 - autoclavable rigid medical endoscopes and endoscopic medical instruments instructions for use and processing instructions.F.Inspection, handling and maintenance.1.Arthrex endoscopes and endoscopic medical instruments are precision medical instruments and must be used and handled with care.4.Do not subject the endoscope and endoscopic medical instruments to impact.Put the endoscope and endoscopic medical instruments down carefully.6.Do not bend the sheath or use as a prying tool.
Event or Problem Description
On 6-apr-2026, it was reported by a sales representative via (b)(4) that an ar-3373-4202 sheath is frayed at the distal tip.Noticed during a case with no patient effect.

• 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: 25055627
• Report Number: 1220246-2026-02602
• Device Sequence Number: 10180115
• 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
• Report Date (Section B): 05/01/2026

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
• Distributor Facility Aware Date: 04/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown