A review of the non-conformance database was conducted and there were no documented deviations for this lot.The package insert states "the tip of the instrument is extremely thin and delicate, care should be taken to avoid applying significant pressure to the tip.If excessive pressure is applied to the tip of the instrument, it will bend, rendering it useless.This elevator is not intended for use when removing a tooth that is not loose in the socket." upon evaluation the tip of the instrument was found to be chipped and the fragmented piece was not returned.There were no indications of manufacturing defects.The most likely underlying cause of the complaint issue is excessive force applied by the user.There are no adverse effects reported as a result of this event, however the device malfunction is subject to the two year rule.
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