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

Catalog Number	690016
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
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 25march2025 medwatch (mw5167646) was received by anika.It was reported that when pressing down on the monovisc syringe plunger, one of the barrel finger flanges broke off during the knee injection on a patient of unknown age and demographic.The hcp attempted to draw back on the plunger after experiencing resistance with the initial attempt at delivery of the syringe contents.The hcp used a 22-gauge 3.5-inch syringe.There was no defect with the device or packaging observed prior to the use of the device.There was no negative patient or user impact reported.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report: the reported event is confirmed based on analysis of retention inventory of the same lot.The batch record was reviewed and there was no nonconformances related to the reported event.The lot was manufactured and released to applicable procedures and specifications.The actual sample was not returned for analysis.On all 12 samples the product was easily delivered using a 18-20-gauge needle.However significant resistance was encountered when testing the delivery using a 22-gauge needle.The ifu was reviewed: warnings, temperature storage, handling precautions, and general device-specific information are sufficiently documented in the ifu.Under directions for use: "remove the protective rubber cap on the tip of the syringe and securely attach a small gauge needle (18-20 gauge) to the tip.Twist the tip cap before pulling it off, as this will minimize product leakage." is documented.A three-year retrospective review of all nonconformances was performed.There was no nonconformances related to the reported event.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 most recent stability study report was performed.The conclusion of the report states that the product met all required specifications.The cause the reported event was traced to use error; the user reported using a 22 gauge needle which is not recommended per the ifu.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 march 25, 2025, medwatch (mw5167646) was received by anika.It was reported that when pressing down on the monovisc syringe plunger, one of the barrel finger flanges broke off during the knee injection on a patient of unknown age and demographic.The hcp attempted to draw back on the plunger after experiencing resistance with the initial attempt at delivery of the syringe contents.The hcp used a 22-gauge 3.5-inch syringe.There was no defect with the device or packaging observed prior to the use of the device.There was no negative patient or user impact reported.
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 25march2025 medwatch (mw5167646) was received by anika.It was reported that when pressing down on the monovisc syringe plunger, one of the barrel finger flanges broke off during the knee injection on a patient of unknown age and demographic.The hcp attempted to draw back on the plunger after experiencing resistance with the initial attempt at delivery of the syringe contents.The hcp used a 22-gauge 3.5-inch syringe.There was no defect with the device or packaging observed prior to the use of the device.There was no negative patient or user impact reported.
Additional Manufacturer Narrative
This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report: the reported event is confirmed based on analysis of retention inventory of the same lot.The batch record was reviewed and there was no nonconformances related to the reported event.The lot was manufactured and released to applicable procedures and specifications.The actual sample was not returned for analysis.On all 12 samples the product was easily delivered using a 18-20-gauge needle.However significant resistance was encountered when testing the delivery using a 22-gauge needle.The ifu was reviewed: warnings, temperature storage, handling precautions, and general device-specific information are sufficiently documented in the ifu.Under directions for use: "remove the protective rubber cap on the tip of the syringe and securely attach a small gauge needle (18-20 gauge) to the tip.Twist the tip cap before pulling it off, as this will minimize product leakage." is documented.A three-year retrospective review of all nonconformances was performed.There was no nonconformances related to the reported event.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 most recent stability study report was performed.The conclusion of the report states that the product met all required specifications.The cause the reported event was traced to use error; the user reported using a 22 gauge needle which is not recommended per the ifu.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored and trended for future analysis.Supplemental report: an additional 10 retain samples were pulled for the reported lot.The extrusion force was tested across the 18-gauge, 20-gauge, and 21-gauge needles.It was observed that the five 18-gauge needle samples were around 8lbf, three 20 gauge-needle samples were around 14lbf, and the two 21-gauge needle samples were around 17-18lbf.The physician used a needle size (22-gauge) outside the recommended gauge needle size range (18 to 20-gauge) according to the eifu for monovisc usa (gmp-artwork-0455).The 22-gauge needle was difficult to inject, but the 18-gauge was easy to inject.This case will 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; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 21785410
• Report Number: 3007093114-2025-00005
• Device Sequence Number: 18311751
• Product Code: MOZ
• UDI-Device Identifier: 00817337000104
• UDI-Public: 00817337000104
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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 Catalogue Number: 690016
• Device Lot Number: 0000011005
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/16/2025; 05/09/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 04/16/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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