MAUDE Adverse Event Report: ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION

Catalog Number	630254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing plant.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2024 the distributor reported that a orthovisc syringe broke during the injection.It was indicated that the break occurred at the luer lock location of the glass syringe.There was no negative patient or user impact reported.Additional information was solicited.
Additional Manufacturer Narrative
The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing plant.Supplemental report: the reported event is not confirmed.Additional information was not provided upon request.The device was not returned for analysis.The batch record was reviewed.There was no nonconformances related to the reported event.The lot was manufactured and released to applicable procedures and specifications.A three year retrospective review of all retention inspection reports was performed.There was no nonconformances related to the reported event.A review of the recent stability study report was performed.Here were no non-conformances documented.The conclusion for the product stated that the product has met all required specifications and tolerances.The cause of the reported event cannot be established.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored and trended for future analysis.
Event or Problem Description
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 19dec2024 the distributor reported that a orthovisc syringe broke during the injection.It was indicated that the break occurred at the luer lock location of the glass syringe.There was no negative patient or user impact reported.Additional information was solicited.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 21150644
• Report Number: 3007093114-2025-00002
• Device Sequence Number: 15737018
• Product Code: MOZ
• UDI-Device Identifier: 00817337000111
• UDI-Public: 00817337000111
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: 09/20/2026
• Device Catalogue Number: 630254
• Device Lot Number: 0000010772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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