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

Catalog Number 630254

Device Problem Break (1069)

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

Event Date 01/01/2024

Event Type  malfunction  

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 at the manufacturing plant.

Event 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 (b)(6) 2024 the distributor reported to anika that during an orthovisc treatment in the patient's knee the orthovisc syringe broke at the luer lock.There was no negative patient or user impact reported.The healthcare provided reportedly has 5+ years' experience with orthovisc.There was no report of any defects with the packaging or device prior to use.The procedure was completed with another orthovisc syringe.Additional information was solicited.

Event 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 (b)(6) 2024 the distributor reported to anika that during an orthovisc treatment in the patient's knee the orthovisc syringe broke at the luer lock.There was no negative patient or user impact reported.The healthcare provided reportedly has 5+ years' experience with orthovisc.There was no report of any defects with the packaging or device prior to use.The procedure was completed with another orthovisc syringe.Additional information was solicited.

Manufacturer Narrative

This case is still under investigaton.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing plant.The reported event is not confirmed.It was reported that the syringe broke during an injection.There was no negative patient or user impact reported.There was no delay in the procedure reported.A replacement syringe was used to complete the procedure.There was no damage to the packaging reported.The device was not returned for analysis.The batch record was reviewed.There was no nonconformances in the batch record.The lot was manufactured and released to applicable procedures and specifications.A three-year retrospective review of all nonconformances was performed for the product.There was no nonconformances related to the reported event.Samples of the lot are held for retention.However, the annual inspection was not yet performed for this lot.A three-year review of the retention inventory was performed.There was no nonconformances related to the reported event documented in the inspection reports.A review of the stability study report for (orthovisc) was performed.There was no nonconformances documented in the stability study report.The conclusion for the product stated that the product has met all required.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: ORTHOVISC
• 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: 18970898
• MDR Text Key: 339336370
• Report Number: 3007093114-2024-00005
• 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,Followup
• Report Date: 04/15/2024

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 Catalogue Number: 630254
• Device Lot Number: 0000009107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other