The product analysis result indicates that the cutting tip was detached from the distal end which would have resulted in the reported event.The portion that became detached measured 0.50¿.The teflon bushings showed deformation, and the shaft showed wear which indicates use.The evidence and biological contaminants are not consistent with the issue occurring before use.The customer insinuated that the tips were damaged upon opening the package however this would have been immediately noticeable to manufacture ¿if¿ the issue were present at that time.The manufacturing instructions require a 100% visual and pull test during production to ensure the tip is securely fastened to the bur assembly.A review of the global complaint data showed no other complaints for either lot identified on this event and no complaints for this part number in the last 12 months; in contrast, this facility reported an issue with both on the same day with the same failure mechanism.The information most likely indicates the damage occurred during use.In the returned condition, there was an out of specification condition that is likely related to the complaint (due to physical damage).The most likely underlying cause is consistent with, misuse / use error.If information is provided in the future, a supplemental report will be issued.
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