MAUDE Adverse Event Report: ARTHREX, INC. SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE; ARTHROSCOPE AND ACCESSORIES

Model Number	SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/11/2024, it was reported by a sales representative via sems-(b)(4) that an ar-3372-2401 sheath or ar-3372-2402 sheath in combination with ar-3350-2430 arthroscope, 30° results in inadequate fluid flow through the joint which caused air bubbles to form.When this happened, they needed to wait before resuming surgery.Case completed without harm to the patient.There was no issue when ar-3350-2470 arthroscope 70° was used with the same sheath.The rep suspects this is because the tip of the 70-degree scope sticks out of the end of the sheath slightly.This was discovered during a procedure, with no reported patient harm.Additional information was received on 07/17/2024: the sheath used with the 30-degree scope was the same exact sheath used with the 70-degree scope.It was used in the same case but only tested the 70-degree scope and was not used in the joint.The 30-degree scope was the one used for the case, but it was tested both outside of the joint to see the flow between the two.The pump tubing was primed before the start of the case.This occurred during an ankle scope procedure.Additional information was received on 7/22/2024: this occurred on (b)(6) 2024 during an ankle scope procedure.The surgeon was able to complete the case but due to the bubbles in the joint the case took longer to complete.The case was fairly quick even with the case taking slightly longer and no added anesthesia was administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated usage/reprocessing.Manufactured date: 06-dec-2016.

• Brand Name: SHEATH, 2 STOPCOCK FOR 2.4MM SCOPE
• Common Device Name: ARTHROSCOPE AND 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: 19937943
• Report Number: 1220246-2024-07088
• Device Sequence Number: 7319213
• Product Code: NBH
• UDI-Device Identifier: 00888867198470
• UDI-Public: 00888867198470
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 07/02/2025

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, 2 STOPCOCK FOR 2.4MM SCOPE
• Device Catalogue Number: AR-3372-2402
• Device Lot Number: 1432452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2016
• 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