No patient information provided as no patient was involved in this concern.Unique device identification (udi) unavailable.Device manufacturing date is, therefore, unavailable.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that the reported event was unrelated to a software issue.The universal drill guide (udg) is a calibrated instrument and as a result, you can accidentally verify the instrument outside of the divot causing this behavior.The software functioned as designed.
|
Medtronic received information regarding a navigation device being used outside a procedure.It was reported that while verifying a universal drill guide (udg), it was discovered that the udg would verify at approximately 1cm from the divot.The udg would verify inside the divot just fine, however the udg would consistently pass verification outside of the divot (on both demo spine model and spine air frame).The behavior was repeated on a different udg and other trackers.The instrument would pass no matter how egregious the divot errors they ranged from 4-16mm.The instrument would navigate inaccurately following a successful verification.This was discovered during a spine tray inventory and there was no patient present when this issue was identified.
|