MAUDE Adverse Event Report: ARTHREX, INC. NANONEEDLE HIGH FLOW OPERATIVE KIT 125MM; ARTHROSCOPIC ACCESSORIES

Model Number	NANONEEDLE HIGH FLOW OPERATIVE KIT 125MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 2/22/2024, it was reported by a sales representative via (b)(4) that an ar-3210-0051 nanoneedle high flow operative facility had the pump in use for inflow only.They were also using a high flow nanoneedle and nanoscope during the procedure.They encountered an issue with the inflow going up to 40 and then dropping immediately.This was discovered during a procedure.The case was completed with another device with no patient harm.Tech support tried troubleshooting.
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 user error of the device due to misaligned connection which may result in pump pressure errors.

• Brand Name: NANONEEDLE HIGH FLOW OPERATIVE KIT 125MM
• 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: 18896901
• Report Number: 1220246-2024-01451
• Device Sequence Number: 6152966
• Product Code: NBH
• UDI-Device Identifier: 00888867419230
• UDI-Public: 00888867419230
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/05/2025

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: NANONEEDLE HIGH FLOW OPERATIVE KIT 125MM
• Device Catalogue Number: AR-3210-0051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown