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

Model Number 690-016

Device Problem Break (1069)

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

Event Date 09/30/2021

Event Type  malfunction  

Event Description

On 30sept2021 it was reported to anika that during a knee injection, the monovisc syringe broke.There was no art of the syringe touching the patient.There was no patient impact reported.A replacement monovisc syringe was used to complete the treatment.There was no reported delay to the procedure.Additional information was solicited.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant investigation.

Event Description

On (b)(6).2021 it was reported to anika that during a knee injection, the monovisc syringe broke.There was no art of the syringe touching the patient.There was no patient impact reported.A replacement monovisc syringe was used to complete the treatment.There was no reported delay to the procedure.Additional information was solicited.Supplemental information as of (b)(6).2021; additional information was not provided upon request.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant investigation.(b)(6).2021, supplemental report: the device was not returned to the manufacturing plant upon request.There was no patient impact reported.A review of the lot batch record was reviewed.There was one non-conformance documented in the manufacturing record.The non-conformance is not related to the reported event.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 THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12864347
• MDR Text Key: 282624367
• Report Number: 3007093114-2021-00314
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• 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,Followup
• Report Date: 11/29/2021

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
• Device Operator: Health Professional
• Device Model Number: 690-016
• Device Catalogue Number: 690018
• Device Lot Number: 0000005505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1