It was reported that before the case, the handpiece was calibrated but it would not home.After attempting to move the gears manually and lubricating them, there was not possible to get the handpiece home.The handpiece was replaced in order to start with the case.The results of investigation indicate that the drill guide support is bent, which is a reportable malfunction.
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H10: the device, intended for use in treatment, was returned for investigation.The probable cause of the issue was a mechanical component failure.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.A relationship between the device and the reported event could be established.Visual inspection confirmed that there appeared to be damage to the drill guide support.Functional testing with a long attachment also indicated damage to the drill guide support and a functional homing test failed.Using a reduced long attachment (the barrel end was removed), the handpiece was able to home, confirming that the causes is a bent drill guide support.The malfunction is likely due to mechanical component failure from bending of the handpiece drill guide support.The material has been changed to stainless steel to increase durability and reduce deformation in the field.
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