MAUDE Adverse Event Report: ARTHREX, INC. MAIN PUMP TUBING; ARTHROSCOPE AND ACCESSORIES

Model Number	MAIN PUMP TUBING
Medical Device Problem Codes	Collapse (1099); No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/24/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6410 arthoscopy main pump tubings black inner rubber collapsed.This occurred during use.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information provided on (b)(6) 2025 where it was stated this even occurred on (b)(6) 2025.An arthrex pump was not utilized during this event.The pump and tubing were used to complete the case.There was no clamp/pressure test done.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed by the attached picture, which shows the neoprene sleeve collapsed.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 improper unplugging and plugging of the connector into the no arthrex pump utilized during this event creating a sleeve collapse and pressure failure on the pump.

• Brand Name: MAIN PUMP TUBING
• 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: 22541989
• Report Number: 1220246-2025-02951
• Device Sequence Number: 15203847
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: (01)00888867118010(11)240601(17)290531(10)77874143
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2025

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: MAIN PUMP TUBING
• Device Catalogue Number: AR-6410
• Device Lot Number: 77874143
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 09/26/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/18/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown