Reported event: -customer reported that the long t-bar of the leg positioner has flakes of the black carbonfiber flaking off.Device evaluation and results: -device evaluation was not performed and the leg positioner tray kit event was not confirmed.Device history review: -no product history review could be completed.The pn and lot provided by the customer are for the entire leg holder (and its attachment) kit and not a single component.After multiple attempts to reach the customer for further explanation, no information was retrieved.Complaint history review: -no complaint history review could be completed due to missing information.Conclusions: -no product inspection could be completed due to the product not being returned.Per d03391, preventive maintenance identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are required.Corrective action/preventive action: -as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.
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