The reported event could be confirmed, as the returned device matches the reported failure mode.The device inspection revealed the following: the received target device gamma3® shows traces of a frequent and intense use.The printings on the target device were turned from white to fawn; an indication for a high level of sterilization cycles.Furthermore, the printing ¿do not hit¿ is evidently scratched.Several signs of impacts are visible and a destroyed thread for assembling of the strike plate resp.Extraction rod could be verified.Functional inspection: a pre-surgical function test was performed on the target device returned.Sample nail and sample instruments were used.At the distal drill holes a slight contact could be verified.The alleged mis-targeting could be reproduced.Dimensional inspection: due to product condition [signs of impacts, hitting marks] of the returned device, a dimensional inspection was performed at undamaged areas only, which verified the item to be as defined per specification.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.However, due to the age of the device and the several evident signs of damage [signs of impacts, hammer marks] the root cause is rather related to a rough handling in combination with wear and tear of the device, otherwise the problem would have been noticed from the beginning on which has not been the case.Nevertheless, as reported in the current case the surgery was finished in freehand technique which is always an option.Finally, each device suffers from an intense and frequent use and due to damage found it should not be used any longer.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.
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