The reported event could not be confirmed, since the returned device is conforming to specifications and is fully functional.The device inspection revealed the following: the received target device showed normal signs of usage evident by presence of scratches and other marks.No major damage could be observed which could affect the functionality of the device.However, significant hitting marks could be seen on the proximal part of the target device around the head region.A pre-surgical functional check was performed by assembling the returned target device and a sample nail and a sample drill to check the targeting accuracy.Upon assembly, functionality of the target device was fully given.There was no incidence of any drill contact with the nail around any of the holes in the nail.Thus, the alleged issue could not be reproduced and could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, since the device was found to be fully functional and working as intended, the issue is deemed to be user related.A proper functional check prior to the surgery is required as per ifu.Also as a secondary finding, it was communicated that the device has been in use for 6 years whereas the device was manufactured in the year 2022.So a discrepancy at the customer end may be there.If any additional information is provided, the investigation will be reassessed.
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