As reported: "the surgeon inserted a 9mm t2 alpha tibia nail via the suprapatellar approach.Surgeon reamed to 10.5, and measured 320.He chose to use a 300 nail.The canal was narrow and the surgeon would have used an 8mm nail if available.Proximal screws and then distal screws were inserted.After distal screw insertion, surgeon was unable to detach nail holding bolt from the im rod.The surgeon spent ~10 minutes trying to use the ball tip screw driver to disengage the bolt.He was unable to do so.Vice grips were eventually used to remove the screw.Force and counter force had to be use to disengage the screw from the rod and remove the nail adapter / nail holding bolt.".
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The reported event could be not confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the visual inspection has shown that there are wear marks at the edges of the ball tip screwdriver hexagon visible, but the marks have no influence on the functionality of the screwdriver.The function test has shown that the nail holding screw can be tightened and loosened as required with the received screwdriver.A function test with a nail was performed.It was possible to attach the nail adapter and to insert the nail holding screw, the screw could be tightened and loosened with the received ball tip screwdriver without any issues.The complained 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.No product related issue could be detected, the received devices are functional as required.The root cause of the complained malfunction cannot be defined, based on the provided information that the canal was narrow it is possible that there was a high pressure on the devices, which could lead to increased loosening forces.If more information is provided, the case will be reassessed.
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As reported: "the surgeon inserted a 9mm t2 alpha tibia nail via the suprapatellar approach.Surgeon reamed to 10.5, and measured 320.He chose to use a 300 nail.The canal was narrow and the surgeon would have used an 8mm nail if available.Proximal screws and then distal screws were inserted.After distal screw insertion, surgeon was unable to detach nail holding bolt from the im rod.The surgeon spent ~10 minutes trying to use the ball tip screw driver to disengage the bolt.He was unable to do so.Vice grips were eventually used to remove the screw.Force and counter force had to be use to disengage the screw from the rod and remove the nail adapter / nail holding bolt.".
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