Product complaint #(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.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.However, if the product is received at a later date, the investigation will be updated as applicable.
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : oms/dhr review: product code 130720102, work order 9691306 was manufactured on 02-april-2021.All raw materials met specification.11 parts were manufactured to specification.One (1) part from this lot was scrapped: - scrap code a700: ha coating line (hact0001) scrap at the ha inspect process step.This concerns ha coating.There is no correlation between this scrap reason and the failure mode of the complaint.There were four (4) non-conformances associated with this lot, however, there is no correlation being drawn between these nonconformances and the reported event: - nr-0156163 citrisurf 2250 titration for tank 5 on cpss0029, citrisurf concentration was below the required specification - nr-158794 du2894/cig2557an corail thread depth gauge, thread gauge had failed calibration - nr-0159429 scheduled calibration of pressure gauge cig1572, gauge failed calibration - nr-0165781 hipex work order has a foundry value stream porocoat nr (nr-0159429) referenced on the oms history ¿ there was one material reprocessing report (mrr) associated with this lot.- mrr 1443236 relates to reprocessing through the cleanline step.There is no correlation between this reprocessing reason and the failure mode of the complaint.Device history review: there were four (4) non-conformances associated with this lot, however, there is no correlation being drawn between these nonconformances and the reported event.
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