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

Model Number	MAIN PUMP TUBING
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/04/2024, it was reported by an arthrex subsidiary employee via (b)(6) that an ar-6410 arthroscopy main pump tubing sensor was bent.This occurred during a shoulder arthroscopy procedure on (b)(6) 2024 when the procedure was started, the consumable was placed in the equipment, and the solution was purged, there were no problems or alerts until the joint was entered and it did not work properly since almost none of the solution passed, after obtaining another pipe to change, the consumable was looked at in detail and it was observed that the sensor was bent or damaged internally, which is impossible for it to have been damaged during the surgery since the damage was internal.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted the neoprene of the tubing had collapsed.Refer to attachments.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.The most common causes for a flattened/compressed neoprene are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into 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: 20507401
• Report Number: 1220246-2024-08208
• Device Sequence Number: 8380867
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: (01)00888867118010(11)240501(17)290430(10)75369957
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 08/21/2025

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: 75369957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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