Corrected from medtronic xomed inc.To medtronic puerto rico operations co.Analysis found that the inner assembly would spin, and middle would index freely by hand with no unusual resistance.There was no damage to the tip.When viewed under magnification, there was damage to the hubs that is consistent with improper or difficulty loading the device into the handpiece: locking area deformation caused by the back side of the front collet of the handpiece; and deformation of the proximal inner hub chevrons caused by the handpiece drive mechanism.The user¿s guide has detailed instructions for properly loading a bur/blade into the handpiece.There were no loose components.Even with the deformation of the hubs, functionally the device loaded securely into a handpiece, ran at the maximum recommended speed of 3,000 rpm in oscillate mode/direction, and cut saw bone with no issues.There was no allegation of a defect prior to use.A review of the xpi did not indicate any evidence to point to improper manufacturing and there are checks for damage throughout the process.A bur or blade that is not properly loaded would result in improper support from the handpiece, engagement with the suction seal, drive, and locking mechanism.If information is provided in the future, a supplemental report will be issued.
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