A humeral screw was returned for review.As returned, the device is in excellent condition and shows no damage.The screw was functionally tested by screwing it into a mating component, and the screw installed as intended.Device history review indicates the devices were manufactured to specifications.This device is used for treatment.Initial product history search conducted on september 30th 2016 revealed no additional complaints against the related part and lot combination.Surgical notes were not provided.It is stated in surgical technique guidelines that, "if bearings are not flush with the humeral component, difficulty might be encountered during humeral screw insertion.Ensure bearings are fully seated prior to inserting screws." a definite root cause cannot be determined with the information provided.
|