Even if the device was not returned, an image has been provided in trackwise that confirms the reported event ¿sheared off screw head¿.The device could not be returned.It was confirmed that screwdriver blade 62-20130 and drill 91-16007 have been used during the procedure.The screwdriver blade is intended to be used for 2.0/2.3 mm screws, whereas the drill is intended to be used for 2.0/2.3 mm screws up to a length of 7 mm.Conclusively, both blade and drill were appropriate to be used for the affected screw.The following are examples of possible root causes according to the related risk management file: - wrong/ missing information - too much load on implant/ bone (e.G.Due to tmj disorder/disease) - improper insertion/ positioning of implant, - abnormal mental/ physiological condition of patient - wrong implant placement (e.G.Region with reduced bone quality, too much bone compression during screw insertion), - implant was damaged by instrument/screw during bending/shaping/insertion - implant damaged during sterilization (e.G.Gamma radiation) - wrong choice of implant (e.G.Screw too short due to system mixup and / or poorly assembled/used instrument or misleading measuring/identification) 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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