Complaint 2 of 2.Visual inspection has been conducted of the returned product, which revealed the rod was partially distracted with score marks consistent with expected markings due to incremental distraction.X-ray images of the internal components showed no damage and confirmed the rod had been partially distracted.Additionally, x-ray images of the internal components revealed the threaded cap was seated properly between the distraction rod and the housing tube.No issue was observed with the end cap.The rod was functionally tested; during testing the rod was unable to be distracted with manual distractor and external remote controller (erc).The rod failed to be retracted/distracted with fast distractor to perform the stroke test.The confirmed failure mode is "failed to distract"; the rod was not able to be distracted during the investigation process.No objective evidence was found to confirm the failure of 'end cap disengage'.The rod was sectioned, debris buildup was found around the distraction rod, which may have caused reduced functionality.Sectioning of the rod determined that it could not be separated from the housing without use of high force.It is possible that bending forces applied to the rod from patient anatomy/activity may have caused the distraction rod to wedge into the housing tube, which could then cause the rod to become jammed.Review of the device history records revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspections before shipment.
|