The complaint is confirmed for one returned polaris screw for the failure of lacking polyaxial motion, causing mating issues.Medical records were not provided for review.Device evaluation: visual inspection revealed minor scratches on the tulip, but no signs of damage.A functional examination shows that the tulip is frozen and there is no polyaxial movement of the tulip head.The complaint is not confirmed for a crack, however it is confirmed for no polyaxial motion of the tulip head.Potential cause: root cause was unable to be determined.This event could possibly be attributed to forces applied at an off-axis angle.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility: this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.A follow-up report will be submitted if new information is received that changes the information provided in this report.
|
It was reported the polaris screw was found to have a crack at the end of the screw connection during the operation.Another screw was used to complete the operation.No patient impact was reported.However, upon device evaluation by the manufacturer, the screw was found to have lost its polyaxial motion.
|