The reported event could be confirmed, since the reported event of incorrect drilling during distal locking could not be confirmed.The device inspection revealed the following: the target device was returned for evaluation.The visual inspection has shown that the device is in a very used condition, the markings are faded, there are nicks, dents and scratches all over.There are marks from strong hammer blows all over the surface at the impactor interface and there are also dents at the inside of the impactor bore visible.There is crack visible at in the middle of the glass fiber reinforced arm at the crossover form the metal piece.A function test with a 200mm nail (same length as the reported catalog # 3125-1200s) was performed.All distal locking options, dynamic and static, were tested and no deviation could be detected, the drill bit did not touch the nail in any of the positions.The reported malfunction could not be reproduced.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.Visually is the returned target device in a end of life condition as it was obviously often and intense used since it was manufactured in the year 2013.Nevertheless, could the reported distal misdrilling not be confirmed during the performed evaluation, therefore the root cause was attributed to a user related issue.If more information is provided, the case will be reassessed.
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