The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows obvious signs of wear & has impaction marks.Breakage is evident as the device being returned in two pieces.The breakage pattern indicates to be a brittle fracture.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material & manufacturing related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to wear & design related issue.The failure was caused by its intended use.As a device that is manufactured of radel plastic and incurs numerous impaction events, cleaning and sterilization cycles, breakage as noted in this complaint can be expected.However, this event has been escalated to a nc and capa were opened to update the design of this part.If any further information is provided, the complaint report will be updated.
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