Correction: the device was not returned, as was originally expected.Since the device was not returned, a confirmation of the reported event is not applicable.Hence, a metallurgical examination of the device in question could not be performed in order to determine the root cause.The sales representative has mentioned that screwdriver blade 62-20130 has been used during the procedure.The screwdriver blade is intended to be used for 2.0/2.3 mm screws.The following are examples of possible root causes according to the related risk management file: too much/ wrong compression/ torsional/ axial forces.Wrong rotational speed, unintended loads.Bone quality resulting in high torque.Improper blade disengaging.Collision with other implant or instrument.Predrilled hole not deep enough (e.G.Wrong choice of instrument/implant, system mixup, poorly assembled/used instrument).Powered screw insertion with right angled screwdriver.This is confirmed by previous investigations (b)(4) where it was determined that intraoperative screw breakages occurred as a result of too high torsional forces in forced rupture mode during the insertion.Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.Therefore no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.If the device will be returned, the investigation will be re-evaluated.
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