MAUDE Adverse Event Report: ARTHREX, INC. SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE; ARTHROSCOPIC ACCESSORIES

Model Number	SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/25/2025, it was reported by a sales representative via (b)(4) that an ar-3373-4002 sheath has a damaged tip, was hit by a burr.Found during a case with no patient effect.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-3373-4002 batch 1656493 was received for evaluation.Visual inspection revealed that the instrument tip was severely damaged, with bent and missing fragments.Numerous scratches were also observed on the tip and across the entire instrument.A functional test was not performed due to damage to the device.The most likely cause of the reported failure is user error, specifically the device coming into contact with another instrument during use.Directions for use dfu-0073-6, autoclavable rigid medical endoscopes and endoscopic medical instruments, instructions for use and processing instructions.G.Inspection, handling and maintenance.1.Arthrex endoscopes and endoscopic medical instruments are precision medical instruments and must be used and handled with care.6.Do not bend the sheath or use as a prying tool.7.After insertion of the endoscope into the body, do not apply additional flexion to the joint.A piece of a broken endoscope can become lodged in soft tissue and/or disappear from the endoscopic view of the surgical field, and can be left in the patient.

• Brand Name: SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
• 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: 23862885
• Report Number: 1220246-2025-05743
• Device Sequence Number: 9299596
• Product Code: NBH
• UDI-Device Identifier: 00888867198579
• UDI-Public: (01)00888867198579(11)210909(10)1656493
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/22/2025

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,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
• Device Catalogue Number: AR-3373-4002
• Device Lot Number: 1656493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Distributor Facility Aware Date: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown