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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK® II UNIVERSAL TRACKER, CLAMP DRIVER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK® II UNIVERSAL TRACKER, CLAMP DRIVER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 961-584
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/01/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Return requested.Replacement suretrak2 clamp driver shipped to site (b)(4) 2017.No parts have been received by manufacturer for analysis.
 
Event or Problem Description
A medtronic representative reported that a site's suretrak2 clamp driver had stripped screw threads.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.
 
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Brand Name
SURETRAK® II UNIVERSAL TRACKER, CLAMP DRIVER
Common Device Name
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key6599588
Report Number1723170-2017-02140
Device Sequence Number1149028
Product Code HAW
UDI-Device Identifier00721902467660
UDI-Public00721902467660
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K983670
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 05/30/2017
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 Health Professional
Device Catalogue Number961-584
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/01/2017
Initial Report FDA Received Date05/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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