The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Evaluation revealed the target device gamma3® to be the primary device.The device inspection revealed the following: the device returned passed the pre-operative function test as intended.Neither a proximal mistargeting nor a distal mistargeting 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.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.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.If any further information is provided, the investigation report will be updated.
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