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

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

This complaint is in scope of a complaint remediation project and has been identified as a complaint that required a mdr based on either the source of the complaint or the type of complaint and is being reported.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 01february2021 it was reported to anika that during an injection the monovisc syringe broke a the handle.The specific location on the syringe was not reported.There was no negative patient impact reported.There was no delay in the procedure the device was discarded.The lot number was not provided.

Manufacturer Narrative

The reported event was not confirmed.The cause of the reported event could not be established.The lot number was not provided.The batch record was not reviewed.All product manufactured by anika and anika entities are released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.

• Brand Name: MONOVISC
• Type of Device: 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: 17012616
• MDR Text Key: 316203622
• Report Number: 3007093114-2023-00059
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1