MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY CW4 ARTHROSCOPY PUMP; ARTHROSCOPE AND ACCESSORIES

Model Number	SYNERGY CW4 ARTHROSCOPY PUMP
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via *(b)(4) that an ar-6485 pump was pumping 500 ml less.Not aware of a case, no patient was affected.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged ar-6485 synergy cw4 arthroscopy pump serial number: (b)(6) was received for investigation.The returned device was visually inspected and no problems were noted.The returned device was assembled with an ar-6410 lot# 73988853 and was tested and evaluated under normal use conditions to see if the issue reported could be reproduced.The pump was connected to the power and turned on.After selecting the desired pressure, the run button was pressed to start the machine, and the returned device was observed the function as intended.During functional testing, a 1000ml graduated cylinder was used to measure the fluid used by the ar-6485 synergy cw4 arthroscopy pump.Fluid was collected over a period of one minute in three separate instances.For the first sample, the flow rate displayed on the pump ranged from 760-770 ml/min, and the volume recorded in the graduated cylinder was approximately 710ml.For the second sample, the flow rate displayed on the pump ranged from 730-750 ml/min, and the volume recorded in the graduated cylinder was approximately 720ml.For the last sample, the flow rate displayed on the pump ranged from 720-730 ml/min, and the volume recorded in the graduated cylinder was approximately 680ml.These results indicate no problem with the flow rate reading of the ar-6485 synergy cw4 arthroscopy pump.No problem found.

• Brand Name: SYNERGY CW4 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: 20368589
• Report Number: 1220246-2024-07992
• Device Sequence Number: 3745732
• Product Code: HRX
• UDI-Device Identifier: 00888867251182
• UDI-Public: (01)00888867251182(10)11296332
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K024291
• 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): 10/29/2024

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
• Operator of Device: Health Professional
• Device Model Number: SYNERGY CW4 ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6485
• Device Lot Number: 11296332
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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