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

Catalog Number	961-579
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by manufacturer for evaluation.Part not returned for evaluation.
Event or Problem Description
A site representative reported that while outside of procedure the screw head of the medium fighter was outworn.There was no patient present at the time of the issue.

• Brand Name: FIGHTER SURETRAK II UNIVERSAL TRACKER, MEDIUM PASSIVE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6915982
• Report Number: 1723170-2017-04026
• Device Sequence Number: 1239298
• Product Code: OLO
• UDI-Device Identifier: 00721902467707
• UDI-Public: 00721902467707
• Combination Product (Y/N): N
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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 Number: 961-579
• Device Lot Number: 150115
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1