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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 961-576
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/06/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device mfg date is dependent on the lot# and therefore unavailable.The site never requested a new clamp or returned the suspect clamp, despite multiple attempts by the manufacturer to proceed with the return materials authorization process.Therefore, no analysis is possible.
 
Event or Problem Description
A medtronic representative reported that the screw for the small suretrak clamp was stripped.No patient was present when this issue was discovered.
 
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Brand Name
SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
MDR Report Key6398496
Report Number1723170-2017-01099
Device Sequence Number16329812
Product Code OLO
UDI-Device Identifier00721902467738
UDI-Public00721902467738
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K983670
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) 03/13/2017
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 Number961-576
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/06/2016
Initial Report FDA Received Date03/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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