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

Model Number	9734590
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.The tracker had etching and would still verify if an instrument could get through it.The procedure was completed by switching to a different tracker.
Additional Manufacturer Narrative
The tracker has not been returned for analysis at the time of filing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that the grey tracker was damaged when it was used with a third-party instrument.There was a delay of less than 1 hour to the procedure and no impact to patient outcome as a result of this issue.
Additional Manufacturer Narrative
Additional information provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that the site was able to get the third part instrument out of the tracker and the tracker was put back into the set.There have been multiple cases since then without any tracker issues.

• Brand Name: NAVLOCK TRACKER UNIVERSAL GREY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9182120
• Report Number: 1723170-2019-05172
• Device Sequence Number: 2774709
• Product Code: OLO
• UDI-Device Identifier: 00643169085534
• UDI-Public: 00643169085534
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2019

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: No Information
• Device Model Number: 9734590
• Device Catalogue Number: 9734590
• Device Lot Number: 160729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 10/31/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/31/2019; 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 73