An event regarding a packaging issue involving a bone screw was reported.The event was confirmed.Device evaluation and results: the device and its packaging were not returned.However, an image was provided showing the packaging box with a torn opening flap and an ifu, without the blister pack and the implant.No medical records were received for review with a clinical consultant.No adverse consequences to the patient were noted.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.The reported event was found to be a nonconformance.The potential root cause is more of a human error as the part and blister assembly are required to be visually inspected during the contents to box and sealing operation.This is an isolated occurrence.Not returned.
|