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

Model Number	690-016
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant investigation.
Event or Problem 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.
Additional 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
• Common Device Name: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12864347
• Report Number: 3007093114-2021-00314
• Device Sequence Number: 1765970
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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