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.Received - 1x x-smart cartridge (b)(4).1x x-smart neck (b)(4).1x x-smart head cap (b)(4).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.I note that the cartrigde is blocked.X-smart neck.Various mechanical problem.Ball bearing of the neck is defective.It is not possible to be determined the root cause with certainty.The root cause is either a mechanical problem or a bad maintenance of user.Replaced 1 x x cartridge (b)(4), 1 x x neck (b)(4), and 1 x x head cap (b)(4).Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
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