(b)(4).Review of device history records show the lot released with no recorded anomaly or deviation.The warnings in the package insert state "intraoperative fracture or weakening of the device can occur if excessive force (torque) is applied." without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report one of two for the same event; reference report 0001032347-2017-00486.
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