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

Model Number	REDEUCE PATIENT TUBING W/CONN, 8' LONG
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/23/2020
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.
Event or Problem Description
It was reported that during an acl reconstruction procedure, that took place (b)(6) 2020, the patient developed compartment syndrome.The surgeon noticed the issue when putting the dressings on the patient while still in the procedure room.The surgeon used gravity and massage in attempts to remove the fluid but then had to perform a fasciotomy.This was done while still in the procedure room, immediately after the acl reconstruction had been completed.The patient had not yet left the room.The patient was kept overnight due to the issue.The wounds were closed on (b)(6) 2020 and the patient is scheduled to be discharged on (b)(6) 2020.The pump did not alarm during use and seemed to perform normally.The surgeon requested the pressure be increased several times during the procedure.The pressure started at 35 and ended at 60.There was no fluid coming out of the portals.The following tubings were used with the pump: ar-6411 (lot 40060968) and ar-6421 (lot 40067186).

• Brand Name: REDEUCE PATIENT TUBING W/CONN, 8' LONG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10379302
• Report Number: 1220246-2020-02016
• Device Sequence Number: 3145739
• Product Code: HRX
• UDI-Device Identifier: 00888867118058
• UDI-Public: 00888867118058
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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: 01/31/2025
• Device Model Number: REDEUCE PATIENT TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6421
• Device Lot Number: 40067186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/07/2020
• 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