Visual and dimensional inspection was performed and the screw measured at ø6.55 x 50 mm, compared to the laser marked diameter of ø7.5 x 50 mm. lot hhjr was released in a size of 85 units and inspected september 2018.Device history records were reviewed for this lot and no relevant manufacturing issues were identified. complaint history was reviewed and no similar complaints were identified for this lot. the non-conformance and corrective preventive action investigation performed with the supplier has concluded that this is an isolated occurrence and that the discrepancy was limited to the one screw, described in this report.During the time period when the 7.5 x 50 mm screw lots were in inventory, 6.5 x 50 mm screws were received into inventory.Records show 1 piece from production lot of 6.5 x 50 mm screws was missing.It was concluded that the qc inspector was not using the gage in a "no-go" condition, which may have allowed a smaller shaft diameter to pass the gage.
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