MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PLANAR PASSIVE BLUNT PROBE; 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	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The passive blunt probe was returned to the manufacturer for analysis.Analysis found that the support arm for marker #3 was bent causing the reported high geometry error.Analysis found that the reported event was related to physical damage.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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 a procedure.It was reported that the site has a damaged passive planar probe.The instrument was tested and the geometry error was around 0.5-0.7.The instrument had a high geometry error and it passed verification despite the damage.There was no patient present when this issue was identified.

• Brand Name: PLANAR PASSIVE BLUNT PROBE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8609443
• Report Number: 1723170-2019-02348
• Device Sequence Number: 2065836
• Product Code: HAW
• UDI-Device Identifier: 00763000055387
• UDI-Public: 00763000055387
• 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): 05/14/2019

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: 03/31/2017
• Device Model Number: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 110517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1