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

Model Number	9734450
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.The insertion tool was returned to the manufacture for evaluation.After visual/physical examination the reported issue was confirmed.As reported, the removal tip had been broken from the back end of the returned tool.The philips head remains intact and functional.The manufacture date was not available at the time of reporting.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 removal end of the tool broke off completely.This occurred at the end of the procedure when the nurse was removing the tracker from the tool with the removal/insertion tool.There was no delay to the procedure.No impact on patient outcome.Additional information was received stating that the instrument was not damaged inside of the patient.

• Brand Name: INSERTION TOOL
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10308111
• Report Number: 1723170-2020-01986
• Device Sequence Number: 859977
• Product Code: HAW
• UDI-Device Identifier: 00613994804730
• UDI-Public: 00613994804730
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 9734450
• Device Catalogue Number: 9734450
• Device Lot Number: 140326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1