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

Catalog Number	9734734
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect navlock was returned to the manufacturer for evaluation.The visual inspection found that lines of galling were present.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
Event or Problem Description
A medtronic representative reported that, while in a spinal fusion, the drill used alongside the navlock tracker could not be moved.The surgeon elected to continue the procedure with non-navigated drill bits.No additional information was provided.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
Additional information: a medtronic representative reported that the site was educated on proper drill use when using the navlock alongside the drill.

• Brand Name: NAVLOCK UNIVERSAL GREEN TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6606251
• Report Number: 1723170-2017-02285
• Device Sequence Number: 1170670
• Product Code: OLO
• UDI-Device Identifier: 00643169101968
• UDI-Public: 00643169101968
• 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
• Report Date (Section B): 07/12/2017

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: 9734734
• Device Lot Number: 160512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 160