This follow-up report is being submitted to relay additional information.The complaint was opened because the facility reported the tip of the instrument tip broke off.The modified beck elevator (part# sp-2359, lot# 091917i17 ) was returned for investigation.Visual evaluation showed signs of use as there was minor scratching on the body of the elevator and the tip had fractured off.The complaint is confirmed.The most likely underlying cause of the complaint is that excessive force was used, beyond what the instrument was designed to encounter.There are no indications of manufacturing defects.(b)(4), which is no greater than the occurrence listed in the application fmea.There are no indications of a manufacturing defects and there are no updates to the risk documents needed.The dhr of this product was reviewed and no non-conformance was found.
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