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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC UC DRILL GUIDE TROCAR; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC UC DRILL GUIDE TROCAR; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-522
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/21/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No devices were returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of procedure.It was reported that the universal drill guide (udg) trocar has been bent.There was no patient present when this issue was identified.
 
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Brand Name
UC DRILL GUIDE TROCAR
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8170859
Report Number1723170-2018-06314
Device Sequence Number19197487
Product Code HAW
UDI-Device Identifier00673978089928
UDI-Public00673978089928
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K974161
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/24/2014
Device Model Number960-522
Device Catalogue Number960-522
Device Lot Number100122
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/21/2018
Initial Report FDA Received Date12/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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