The affected anthology posterior hard stem inserters were returned and evaluated.An inspection of the products confirmed the stated failure.From the analysis conducted during this investigation, it was concluded that the devices fractured at the threaded tip, most likely from impact.The broken pieces were not returned.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.A fracture can also be the result of multiple impacts occurring while the inserter is not fully captured in the driver hole platform of the stem.This fracture caused the instrument to become inoperable.The devices were manufactured in 2014 and 2016 and they show signs of significant use and wear.Our investigation included a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.
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