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

Model Number	961-581
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and the black passive surtrak showed a geometry error above.5.No parts have been received by the manufacturer for evaluation.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 site was having issues calibrating the black suretrak before a case.They stated it would prompt them to do calibration, but after that they were not able to complete any of the steps.The manufacturer representative was going to checkout the suretrak and verify the geometry error was within tolerance.The patient was still in there room at the time of the event.There was less than an hour delay in the case.No impact on patient outcome.Additional information was received stating that the procedure was able to continue the case by attaching the black passive suretrak to the instrument and it proceeded to calibrate.They checked the geometry error and it showed.7 while attempting to calibrate.The issue was caused by a high geometry error.

• Brand Name: SURETRAK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9660398
• Report Number: 1723170-2020-00337
• Device Sequence Number: 319393
• Product Code: OLO
• UDI-Device Identifier: 00721902467684
• UDI-Public: 00721902467684
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 961-581
• Device Catalogue Number: 961-581
• Device Lot Number: 150423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 95