There has been a previous report received with a similar device where torque issues have 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.Please note that while this product is not sold in the us, it is considered similar to products that are when taking into account composition and indications for use.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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