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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC DRILL BIT GUIDE; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC DRILL BIT GUIDE; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-524
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/26/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The drill was returned to the manufacture for evaluation.After visual/physical examination the reported issue was confirmed.The returned drill had many lines of galling along the shaft.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that, while outside of a procedure, the drill bit guide was reported to be damaged.There was no patient present when this issue was identified.
 
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Brand Name
DRILL BIT GUIDE
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key10329365
Report Number1723170-2020-02030
Device Sequence Number11485447
Product Code HAW
UDI-Device Identifier00673978089966
UDI-Public00673978089966
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 company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/27/2020
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 Model Number960-524
Device Catalogue Number960-524
Device Lot Number140815
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/23/2020
Initial Report FDA Received Date07/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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