(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 522221.This is a custom version of the 522221 which exists outside the tfx qms.A visual inspection of the device cannot be provided as the device was returned to the manufacturer for review.The manufacturer was unable to determine the source of the flaking.The sample was cleaned and returned to the customer.Root cause unknown and linked to parts or tools that made contact with the device.A visual inspection of the device cannot be provided as the device was returned to the manufacturer for review.The manufacturer was unable to determine the source of the flaking.The sample was cleaned and returned to the customer.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.4 complaints including this one, have been logged for flaking of a custom version of 522221.2 additional complaints were received from the same customer.1 previous instance in 2020 was also noted.Reference- (b)(4): this is a custom version of the 522221 which exists outside the tfx qms.Root cause unknown and linked to parts or tools that made contact with the device.The manufacturer's investigation is available.
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