There were two additional set screws reported to have been loose.They are of the same product part number but contain a separate manufacturing lot number.· 7919703 manufactured 12/20/2016 an investigation of the returned set screws showed that the threads are not deformed which indicates the set screws had not been cross threaded.However, an evaluation of the bottom set screw surface revealed unusual wear marks.The bottom surface is the surface which interacts with the rod to create a stable construct, therefore the wear pattern on this surface may be indicative of the screw performance.The expected set screw bottom surface pattern is as hour glass wear pattern resulting from a fully tightened set screw, normal to rod, with distributed loading of the rod.The explant set screws show wear marks that are unevenly distributed which indicates a non-distributed loading condition.One of the set screw showed wear marks similar to a starburst pattern which indicates partial set screw back out.This starburst pattern being indicative of non-normal loading of the rod under a dynamic loading condition.Based on these findings, the explants indicate that set screw disengagement is a result of a non-distributed loading and non-normalized rod conditions at final lockdown.
|