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	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.No findings possible at this time.Part not received by manufacturer.
Event or Problem Description
A site representative reported that during a spinal fusion procedure, an awl-tipped tap instrument and an instrument tracker became bound together, and could not be separated, or used for navigation.It was reported that the bound parts were used with a power driver.There was a reported delay to the procedure of less than 1 hour due to this issue.The procedure was completed successfully without the use of these instruments, and no impact to the patient or user was reported.
Additional Manufacturer Narrative
Investigation of returned suspect navlock tracker finds that the tracker was returned with an awl tip tap stuck within the handle.After removing the awl tip tap galling lines were found on the mating surfaces of both parts.Otherwise, with markers attached and fully seated, the tracker returned a good geometry error.The reported issue was confirmed to be caused by galling of the instrument.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.
Additional Manufacturer Narrative
Medtronic representative reported that the site was able to navigate with another (b)(6).
Additional Manufacturer Narrative
Patient id and patient age updated to proper values.

• 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: 6058925
• Report Number: 1723170-2016-02747
• Device Sequence Number: 75412
• Product Code: OLO
• UDI-Device Identifier: 00643169101968
• UDI-Public: 00643169101968
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2017

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: Physician
• Device Catalogue Number: 9734734
• Device Lot Number: 121016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 12/16/2016; 01/18/2017; 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 01T50000002G68UAAQ
• Patient Age: 53 YR
• Patient Weight: 95