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

Model Number	9733825
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 outside of a procedure that the ioi mount was damaged.It is unknown how it became damaged.No patient was present at the time of the event.Follow-up with the manufacturer representative (rep) determined that the mount was not usable and was found in spd.The rep thought that the screw was broken and that was the extent of the damage.The issue occurred outside of a procedure.

• Brand Name: MOUNT ASSY
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8452153
• Report Number: 1723170-2019-01344
• Device Sequence Number: 3026538
• Product Code: HAW
• UDI-Device Identifier: 00613994428387
• UDI-Public: 00613994428387
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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: No Information
• Device Model Number: 9733825
• Device Catalogue Number: 9733825
• Device Lot Number: 150422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1