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

Catalog Number	9734590
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturing date is dependent on lot number, therefore, unavailable.Following-up the medtronic representative reported that the instrument trackers do not appear to have any damage and the tips fit without issue.Part return requested.The tray was owned by a msb representative and no replacements required at this time.No parts were replaced.No parts have been received by manufacturer for analysis.
Event or Problem Description
A medtronic representative reported that while in an open spinal fusion procedure, the tracker disc prep inserts would not slide into the navigation trackers.All colors and all inserts were attempted.There was a reported delay to the procedure of less than 1 hour due to this issue.Navigation of disc prep was aborted and the surgeon opted to complete the procedure without the use of the navigation system.There was no impact on patient outcome.
Additional Manufacturer Narrative
Patient age and weight provided.

• 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: 6396762
• Report Number: 1723170-2017-01110
• Device Sequence Number: 10927298
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 9734590
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 82