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

Catalog Number	961-581
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier not available from the site.A medtronic representative went to the site to test the equipment along with the navigation system used within the procedure.The hardware, software, and instruments passed the system checkout.The representative was unable to replicate the reported issue.The system was found to be fully functional.The suspect suretrak has not been received by the manufacturer for evaluation.
Event or Problem Description
A site representative reported that, while in a dese l4-l5 transforaminal lumbar interbody fusion (tlif), the suretrak being used was reported to have difficulties navigating.An imprecision was reported to be in the range of 5mm when using the suretrak as opposed to any other instruments introduced into the surgical field.Aside from the suretrak, the procedure continued as intended.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.

• 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: 6710849
• Report Number: 1723170-2017-02874
• Device Sequence Number: 1464848
• Product Code: OLO
• UDI-Device Identifier: 00721902467684
• UDI-Public: 00721902467684
• 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): 07/13/2017

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: Physician
• Device Catalogue Number: 961-581
• Device Lot Number: 070321
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 87