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

Model Number	REDEUCE PATIENT TUBING W/CONN, 8' LONG
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
On 04/20/2022, it was reported by a sales representative via sems that an ar-6485 synergy cw4 arthroscopy pump had an issue.The pressure was misread, and too much fluid was delivered.This was discovered during use with no impact to the patient.Additional information has been requested.On 04/26/2022, the sales representative provided the following information via email: this event occurred during a knee arthroscopy procedure, arthrex tubing was used with the pump, no extravasation occurred and the complaint pump was used to complete the procedure.The sales representative also stated that day over the phone that both tubing systems were discarded by the facility after the procedure.

• Brand Name: REDEUCE PATIENT TUBING W/CONN, 8' LONG
• 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: 19181251
• Report Number: 1220246-2024-02379
• Device Sequence Number: 20610476
• Product Code: HRX
• UDI-Device Identifier: 00888867118058
• UDI-Public: 00888867118058
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: REDEUCE PATIENT TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6421
• Device Lot Number: 57089212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown