MAUDE Adverse Event Report: ARTHREX, INC. CWIII ARTHROSCOPY PUMP; ARTHROSCOPE AND ACCESSORIES

Model Number	CWIII ARTHROSCOPY PUMP
Medical Device Problem Code	Increased Pump Speed (1501)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2024
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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 04/03/2024, it was reported by a facility representative via (b)(4) that an ar-6475 arthroscopy pump was running at a faster speed than intended.This occurred during a case where there were no error messages corresponding to the problem.The speed of the pump was described as "really fast," even with the clamp off, and it was continuously running.
Additional Manufacturer Narrative
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.

• Brand Name: CWIII ARTHROSCOPY PUMP
• 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: 19190436
• Report Number: 1220246-2024-02429
• Device Sequence Number: 12881917
• Product Code: HRX
• UDI-Device Identifier: 00888867039346
• UDI-Public: 00888867039346
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K024291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: CWIII ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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