MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PROBE 960-556 PLANAR PASSIVE BLUNT; INSTRUMENT, STEREOTAXIC

Model Number	960-556
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The planar probe was returned to the manufacturer for analysis.After visual examination, it was noted that the post for marker #3 has been broken off and is missing.Otherwise, with the remaining markers attached and fully seated, the probe returned good geometry and divot error readings, despite the missing marker, with normal tracking.However, continuity test revealed a short between pin 1 and pin 4 of the usb cable.The hardware investigation found that the reported event was related to a hardware issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system that was used outside of procedure.It was reported that a passive planar probe is damaged.There was no patient present at the time of the event.

• Brand Name: PROBE 960-556 PLANAR PASSIVE BLUNT
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9510787
• Report Number: 1723170-2019-06131
• Device Sequence Number: 1410079
• Product Code: HAW
• UDI-Device Identifier: 00673978090122
• UDI-Public: 00673978090122
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 12/23/2019

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 Expiration Date: 01/26/2014
• Device Model Number: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 090204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1