MAUDE Adverse Event Report: ARTHREX, INC. REDEUCE PUMP TUBING W/CONN, 8' LONG; ARTHROSCOPE

Model Number	REDEUCE PUMP TUBING W/CONN, 8' LONG
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
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 (b)(6) 2021, it was reported by a sales representative via sems that an ar-6411 reduce pump tubing w/conn, 8' long was not registering properly, causing too much fluid to go into the joint.This was discovered during use in knee arthroscopy on (b)(6) 2021.The case was completed using the same ar-6411.Ice was placed on patient post- op to help with fluid build up and swelling went down.

• Brand Name: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12300915
• Report Number: 1220246-2021-03508
• Device Sequence Number: 19624218
• Product Code: HRX
• UDI-Device Identifier: 00888867118027
• UDI-Public: 00888867118027
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6411
• Device Lot Number: 46096059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other