It was reported that there was an issue with a ennovate set screw driver short.During the surgery, an 8.5 ennovate screw could no longer be screwed in.It was extremely fixed.The screwdriver at the tip of the screw broke off.Now it was only possible to provide the screw with a rod and a locking nut and thus turn the whole screw.However, the screw did not move.Now the screw should be unscrewed in this way, because it was still far away from its position and was too high.When turning it back, the body has turned off the shaft.The unscrewing of the stock didn't work with the set screw screwdriver, it deformed at the tip and the screw had to be removed.The adverse event is filed under aag reference (b)(4).Involved component (is not sold to us): sy865ts - ennovate polyax.Screw 9.5 x 50 mm fenestr.Batch: 52412120 (400442652).Associated medwatch reports: 9610612-2019-00622 ((b)(4)).
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