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	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, age and weight were not made available from the site.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested for suspect navlock tracker.No parts have been received by manufacturer for analysis.
Event or Problem Description
A site representative reported that while in a spinal fusion procedure, an awl-tip-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 powerease driver.Alternate instruments were brought in to be used to continue the procedure.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
Additional Manufacturer Narrative
Correction: patient sex provided.Also provided concomitant medical product.Additional information: lot number and device manufacture date provided.
Additional Manufacturer Narrative
Additional information: patient demographics provided.
Additional Manufacturer Narrative
The suspect tracker was returned to the manufacturer for analysis.The tracker was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• 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: 6104678
• Report Number: 1723170-2016-02916
• Device Sequence Number: 1360363
• 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): 04/27/2017

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: 160418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 12/20/2016; 03/17/2017; 04/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1