MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAVLOCK TRACKER UNIVERSAL GREY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734590
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Site representative (b)(6) declined to provide patient information.Return requested for suspect navlock universal gray tracker on (b)(6) 2017.No parts have been received by manufacturer for analysis.Part not received by manufacturer.
Event or Problem Description
A medtronic representative received a report from a site that while in a spine procedure, they broke a grey navlock tracker, as well as two additional instruments.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
Additional Manufacturer Narrative
The grey tracker was returned to the manufacturer for analysis.Reported issue was able to be duplicated.The returned tracker has lines of galling inside causing fit issues with the mating instruments.The hardware investigation found that reported event was related to a mechanical issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: NAVLOCK TRACKER UNIVERSAL GREY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6395366
• Report Number: 1723170-2017-01013
• Device Sequence Number: 16394263
• Product Code: OLO
• UDI-Device Identifier: 00643169085534
• UDI-Public: 00643169085534
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• 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,Followup,Followup
• Report Date (Section B): 07/07/2017

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: 9734590
• Device Lot Number: 160418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: Not provided; 06/09/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/06/2017; 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1