The event is related to the procedure performed on (b)(6) 2020.The surgeon reported that 3 of the screws deviated in position.The first screw inserted was accurate.During the investigation it was found out the surgeon was working though small incision in open procedure which caused for constant rearrangements of retractors and instrumentation handling in close vicinity of the clamp.The augmedics representative suspects that the clamp closing screw was not fully tightened.It was concluded that the clamp was not tighten enough by the surgeon and therefore was moved by the handling of the retractor or instrumentation.The 3 screws were removed and replaced using fluoro.No additional intervention was required.No additional adverse events were reported.The surgeon was re-trained on indication for fully closed clamp.
|