MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRACKER 9734682 NAVLOCK UNIVERSAL VIOLET; INSTRUMENT, STEREOTAXIC

Model Number	9734682
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and serial number were not available at the time of filing.The instrument has not been returned to the manufacturer at the time of filing.Manufacture date was not available 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.It was reported that intra/peri-operatively during the navigate task of a sacroiliac and thoracolumbar procedure, the violet navigated frame component became stuck on a tap because it was damaged.There was no delay to case.There was no reported impact on patient outcome.

• Brand Name: TRACKER 9734682 NAVLOCK UNIVERSAL VIOLET
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7973373
• Report Number: 1723170-2018-05184
• Device Sequence Number: 1645115
• Product Code: HAW
• UDI-Device Identifier: 00763000054298
• UDI-Public: 00763000054298
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 10/17/2018

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: Health Professional
• Device Model Number: 9734682
• Device Catalogue Number: 9734682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1