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

Lot Number 0000002083

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/14/2019

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 16august2019 it was reported to anika that a monovisc syringe broke during a knee injection and leaked.The injection was completed with another syringe.There was no delay to the procedure and there was no negative impact to the patient or user.

Manufacturer Narrative

The reported event is not confirmed.The cause of the reported event is not established.The batch record was reviewed.There was no nonconformances recorded in the manufacturing record.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: MONOVSIC
• 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: 16989017
• MDR Text Key: 315826423
• Report Number: 3007093114-2023-00073
• 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
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0000002083
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2019
• 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