Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Product complaint (b)(4).Complaint record is approved to be converted to an npi on (b)(6) 2023.The noted event, of delivery service issue does not meet the definition of a complaint.There is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a joint reconstruction device, after it was released for distribution.There is no report of an adverse event involving a joint reconstruction device.The only event identified, is a delivery service issue, unrelated to depuy device or procedure.
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