MAUDE Adverse Event Report: ARTHREX, INC. SYNOJOYNT® 1% SODIUM HYALURONATE; HYALURONIC ACID

Model Number	SYNOJOYNT® 1% SODIUM HYALURONATE
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2025
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 3/28/2025, it was reported by a sales representative via email that an 82197-0721-16 synojoynt 1% sodium hyaluronate was used in a patient past its expiration date.The injection was on (b)(6) 2025, and the product expired on 3/14/2025.No further information was provided.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 of the device due to the facility not updating the inventory.

• Brand Name: SYNOJOYNT® 1% SODIUM HYALURONATE
• Common Device Name: HYALURONIC ACID
• 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: 21941345
• Report Number: 1220246-2025-01814
• Device Sequence Number: 21112645
• Product Code: MOZ
• UDI-Device Identifier: 00888867413689
• UDI-Public: (01)00888867413689(11)230401(17)250314(10)102523003
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P170016
• 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): 09/15/2025

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 Expiration Date: 03/14/2025
• Device Model Number: SYNOJOYNT® 1% SODIUM HYALURONATE
• Device Catalogue Number: 82197-0721-16
• Device Lot Number: 102523003
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown