Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
|
Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.Manufacturing date: (b)(6) 2023 expiry date: (b)(6) 2025 quantity: 4260 there were zero non conformances on this lot.All qc and microbiology testing met specification.A review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.A manufacturing record evaluation was performed for the finished device product (b)(4), lot 4147848, and no non-conformances / manufacturing irregularities were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot - a manufacturing record evaluation was performed for the finished device product (b)(4), lot 4147848, and no non-conformances / manufacturing irregularities were identified.H10 additional narrative: added: h4.
|