MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PASSIVE PLANAR BALL 1.5MM; INSTRUMENT, STEREOTAXIC

Model Number	960-559
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The probe was returned for analysis.Through visual and functional testing methods it was determined that with markers attached and fully seated, the returned probe was not able to verify displaying high geometry and divot error readings.The support arm for marker #3 is bent causing the high geometry error and the tip is bent causing the high divot error.Physical damage was confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation instrument outside of procedure.It was reported that a damaged passive planar ball was noticed pre-operatively when verifying instruments.The probe was flashing in the tracking window and the error was hovering around.47 to.5.The case was done using another probe from another tray.No patient was present.

• Brand Name: PASSIVE PLANAR BALL 1.5MM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8604936
• Report Number: 1723170-2019-02316
• Device Sequence Number: 2350023
• Product Code: HAW
• UDI-Device Identifier: 00673978090153
• UDI-Public: 00673978090153
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K972398
• 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
• Report Date (Section B): 05/13/2019

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: 960-559
• Device Catalogue Number: 960-559
• Device Lot Number: 150331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1