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

Model Number	9734450
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter information was unavailable.No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the insertion/removal tool instrument was found to be damaged in the sterile processing department (spd).The insertion/removal tool was reported to be chipped/stripped.There was no patient present.
Additional Manufacturer Narrative
Additional information: initial reporter information has been updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INSERTION / REMOVAL TOOL
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8334257
• Report Number: 1723170-2019-00635
• Device Sequence Number: 14033831
• Product Code: HAW
• UDI-Device Identifier: 00613994804730
• UDI-Public: 00613994804730
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: Health Professional
• Device Model Number: 9734450
• Device Catalogue Number: 9734450
• Device Lot Number: 170127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1