MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION INSTRUMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734678
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.A manufacturer representative went to the site to test the equipment.It was reported that the instruments will be replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The awl was returned to the manufacturer for analysis.Analysis found that the returned instrument had impact marks at the back end causing fit issues with mating trackers as reported.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware tracking database.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system during a sacroiliac and thoracolumbar procedure.It was reported that all the parts of the nav lock set were unable to be attached smoothly.The procedure was completed with the use of navigation.The surgery was completed with no delay and no patient injury.

• Brand Name: NAVIGATION INSTRUMENT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7996762
• Report Number: 1723170-2018-05307
• Device Sequence Number: 289555
• Product Code: OLO
• UDI-Device Identifier: 00613994870049
• UDI-Public: 00613994870049
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: 9734678
• Device Catalogue Number: 9734678
• Device Lot Number: 161010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1