(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 354965.(1) sample of 354965 lot j9 was received with a broken jaw.The fracture plane was inspected under magnification to determine that the failure was sudden and did not progress over time.The direction of the plane suggested that the jaws were overloaded parallel to the range of movement.This is consistent with use on oversized needles or tray damage.A dimensional inspection was not required as part of this investigation.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 354965.The device is not functional in current state.The damage observed is consistent with overstressing the jaws in use or cleaning due to improper tray loading.
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