The returned sleeve was examined.There was evidence of use (scratches) but no signs of damage or deformation.When functionally tested with mating parts, the connection between the sleeve and the pedicle screw was slightly loose, allowing the screw to wiggle slightly, but the device was operational.A review of the manufacturing records did not identify any issues which may have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding proper device usage.Reference reports 0002184052-2016-00150 and 3004485144-2016-00404.
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The sales associate reported non-functional instruments.During a case, the sleeves were unable to be used during the nxt case.It was reported that the sleeves have started to splay at the bottom, not allowing the screws to sit in the grooves correctly and therefore not letting the screwdrivers to be seated in the screw head.The surgery was completed using the short sleeves and pins.The doctor had to change technique from true percutaneous because the short sleeves were not long enough for the obese patient to allow a mini open type approach.This is report three of three for this event.
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