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 (b)(6)2023 it was reported to anika that during a knee injection, the orthovisc syringe broke.There was no negative patient and user impact.Another device was used to complete the procedure.The lot number is unknown.The device was discarded.
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