MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PLANAR PASSIVE 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	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was not returned, so no analysis was performed.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 tip of the passive probe ball chip was deformed.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
The probe was returned to the manufacturer for analysis.Analysis found that the tip of the returned passive probe was slightly bent.However, with markers attached and fully seated, the probe returned good geometry and divot error readings.Analysis found that the reported event was related to physical damaged.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.

• Brand Name: PLANAR PASSIVE BALL 1.5MM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8520467
• Report Number: 1723170-2019-01792
• Device Sequence Number: 1474372
• Product Code: HAW
• UDI-Device Identifier: 00673978090153
• UDI-Public: 00673978090153
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2019

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: 160711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1