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

Model Number NANONEEDLE HIGH FLOW OPERATIVE KIT 125MM

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

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 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.

• Brand Name: NANONEEDLE HIGH FLOW OPERATIVE KIT 125MM
• Type of Device: 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
• MDR Text Key: 337584475
• Report Number: 1220246-2024-01451
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867419230
• UDI-Public: 00888867419230
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Model Number: NANONEEDLE HIGH FLOW OPERATIVE KIT 125MM
• Device Catalogue Number: AR-3210-0051
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1