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

Model Number	MAIN PUMP TUBING
Medical Device Problem Codes	Increase in Pressure (1491); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 9/11/2024, a sales representative reported via (b)(4) that an ar-6410 main pump tubing malfunctioned during a shoulder surgery.The tubing was connected to an ar-6485 (serial number: (b)(6)).The pump was set at a flow rate of 20.During surgery, the patient's shoulder became excessively swollen.The surgery was completed without replacing the pump tubing.No information was available regarding whether the membrane had collapsed, what treatment was given to the patient, or whether the hospital stay was extended.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.One unpackaged ar-6410 serial/batch number (b)(6) was received for investigation.Functional testing with the ar-6480 dual wave pump and water for 22 minutes found that the device was working as intended.No issues with the pressure were noted during the test.According to the complaint's allegation, the tubing was connected to the ar-6485 serial number (b)(6).It was also reported but never received for evaluation.However, it was found that the facility reported the device again in november 2024.A visual evaluation revealed no issues.No problem found.

• 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: 20396738
• Report Number: 1220246-2024-08028
• Device Sequence Number: 17762170
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: (01)00888867118010(11)240201(17)290131(10)73988863
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083707
• 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): 01/31/2025

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 Lot Number: 73988863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2024
• 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