MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK2 UNIVERSAL TRACKER,LARGE PASSIVE FIGHTER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	961-581
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Site dr.(b)(4) declined to provide patient information.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect suretrak2 large pass fighter tracker.No parts have been received by manufacturer for analysis.No further issues have been reported.
Event or Problem Description
A medtronic representative reported that, while in a spine procedure, the site's suretrak2 large passive tracker was damaged.A sphere post came off of the instrument.No further details regarding the damage, or how it occurred, were provided.A second suretrak2 tracker was brought in and used to continue the procedure.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

• Brand Name: SURETRAK2 UNIVERSAL TRACKER,LARGE PASSIVE FIGHTER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6167776
• Report Number: 1723170-2016-05781
• Device Sequence Number: 16245186
• Product Code: OLO
• UDI-Device Identifier: 00721902467684
• UDI-Public: 00721902467684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• 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,Followup
• Report Date (Section B): 01/05/2017

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: 961-581
• Device Lot Number: 100331
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention