A sample and pictures were returned for investigation.The pictures were visually inspected, and the blue chip was missing; no other discrepancies were found.The sample failed the arch height tube measure.A functional test was performed, and no discrepancies were detected.The product primed without difficultly.The reported failure was not confirmed.The root cause cannot be determined as no fault was found.A device history review (dhr) was performed, and no problems or issues were identified during this dhr review.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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