MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INST 960-717 ADJ DRILL STOP, 3.2MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
|
Back to Search Results |
|
Catalog Number 960-717 |
Device Problem
Imprecision (1307)
|
Patient Problems
No Consequences Or Impact To Patient (2199); Injury (2348)
|
Event Date 03/09/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Patient information was not made available from the site.Device lot number is unavailable.Device manufacturing date is dependent on lot number, therefore, unavailable.On (b)(6) 2017 a medtronic representative, following-up at the site, reported that he inspected all three sets that included inst adj drill stop 3.2mm.All instruments were tested and found to be functioning properly, no issues were identified.It was deemed likely the drill stop used in this event was not properly locked in place, allowing the drill to go deeper than desired.The site sterile processing department (spd) head and technicians were all re-trained on the use of the 3.2mm inst adj drill stops and demonstrated they understood locking/unlocking of the device correctly.No parts will be returned to the manufacturer for analysis as there are no malfunctions.This event was determined to be use error.The site confirmed the patient in this event suffered no injury and was recovering "just fine", as expected.There are no further issues.
|
|
Event Description
|
A medtronic representative received a report on (b)(6) 2017, alleging that on (b)(6) 2017, while in a spine procedure, the site's universal drill guide (udg) drill stop was not functioning properly, and the drill went deeper than expected.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
|
|
Manufacturer Narrative
|
Type of event, adverse event updated as the reported issue was found to be an adverse event due to the drill going deeper into patient than intended.
|
|
Search Alerts/Recalls
|
|
|