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 29january2019 it was reported to anika that during a monovisc injection, the syringe needle broke.The break occurred at the luer lock.The case was completed with another syringe.There was a 15 minute delay in the procedure.The device was returned to the manufacturing plant for analysis.
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