The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Although a real root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error.Nevertheless, according to event description the surgery was completed using the ¿freehand technique¿, which is always an option.The device inspection revealed the following: the device returned passed the pre-operative function test as intended.Neither a proximal "mis-targeting" nor a distal "mis-targeting" could be confirmed.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event was mainly based in the intra-operative procedure.Reasons for misaligned drilling are various.Potential miss-targeting can also be caused but is not limited by e.G.Loosening of the nail holding bolt during insertion of the nail.Repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended.Not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve).No use of drill with centre tip / unfavourable bone contour.Drilling without drill guiding sleeve.Using blunt or damaged drill.High forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
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