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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UNIVERSAL DRILL GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UNIVERSAL DRILL GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 960-521
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/13/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
 
Event or Problem Description
A medtronic representative reported that, while outside of a procedure, the universal drill guide would not tighten sufficiently.It was noted that the internal portion for the screw was stripped.There was no patient present when this issue was identified.No additional information was provided.
 
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Brand Name
UNIVERSAL DRILL GUIDE
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key7102686
Report Number1723170-2017-05053
Device Sequence Number16627807
Product Code HAW
UDI-Device Identifier00673978089904
UDI-Public00673978089904
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K974161
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 12/08/2017
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 Physician
Device Catalogue Number960-521
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2017
Initial Report FDA Received Date12/10/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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