MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FIGHTER SURETRAK II UNIVERSAL TRACKER, LARGE PASSIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	961581
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A site representative reported that the black suretrak tracker had a stripped screw.No patient was present during the time of the reported incident.

• Brand Name: FIGHTER SURETRAK II UNIVERSAL TRACKER, LARGE PASSIVE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6350723
• Report Number: 1723170-2017-00463
• Device Sequence Number: 799088
• Product Code: HAW
• UDI-Device Identifier: 00721902672309
• UDI-Public: 00721902672309
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2017

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 Number: 961581
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1