There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.X-smart casing assembly.Various mechanical problem.Inside of the handpiece casing is broken.X-smart head cap.Bad maintenance (user).The file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.X-smart cartridge: various mechanical problem, the file does not fit on the contra angle because hook of cartridge is broken.X-smart neck: other rotation not fluid.Replaced 1 x x cartridge h1004c5210150, 1 x x neck h1004c5470220, 1 x x head cap h1004c5210500 and 1 x x casing assembly h1004e2810010.
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