Manufacturing site evaluation: investigation - the implant arrived in a decontaminated condition.The tip of the instrument is broken off.The broken off pieces are not enclosed.A visual inspection was performed of the fracture surface.Typical signs of fracture caused by high torque are seen.The direction of the fracture lines indicate clockwise torque.Batch history review - the manufacturing documents have been checked and found to be according to specifications during the time of production.There are no further complaints with this lot at hand.Conclusion and root cause - the root cause for the problem is most probably usage related.Rationale - the fracture of the instrument occurred during high torque screwing of a pedicle screw.Without further knowledge of the circumstances, it is most probable that the screw hole was not prepared properly and the screw seized up.The attempt of further screwing in is the most probable cause of high torque.A material defect or manufacturing error can be excluded.Corrective action: according to sa de13-m-4-2-04-000-0 there is no capa necessary.Should further information regarding this case become available, a supplemental report will be submitted.
|
It was reported that there was an intraoperative issue with an ennovate screw that resulted in a surgical delay.The reported case involved a revision fortex system with lumbar 2 -5 implantation of ennovate at thoracic 10 - lumbar 5.This ennovate screw was implanted using the applicable screwdriver.On x-ray, the screw should then be turned further into the pedicle, breaking off the torx.Screw was then unscrewed with the 2nd sz381r to cut thread.While removing it there was a loud crack and the screw broke into 2 parts.One part remained in the patient and could not be unscrewed as it "sat too low".Surgery was delayed 15 minutes.Details about the surgical outcome and patient data were not provided.Additional information has been requested.Associated medwatch: 9610612-2019-00459 (sy646ts- screw).
|