There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.Battery (voltage breaks down under load) defective, replaced.Motor bracket (broken) defective, replaced.Motor connection cable (broken cable) defective, replaced.The housing has cracked in several places (presumably due to an impact) has no effect on the function.Micromotor (b)(4) and contra-angle handpiece (b)(4) (2011) tested, without defects.Function test and test measurements without errors.
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