This submission is for the 2q17 asr malfunction events for rotary niti file breakage under (b)(4).This report summarizes 104 malfunction events.There were 79 events where file breakage resulted in no consequences or impact to the patient.There were 25 events where the patient outcome is unknown despite multiple attempts to obtain the information.Fifty (50) of the devices were not returned for evaluation.We received 54 of the 104 devices for evaluation, of which: 30 of the devices were found to be within specification.Twenty-four (24) of the devices were received in a condition making evaluation impossible.
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