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	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The probe was returned to the manufacturer for analysis.Analysis found that the returned probe was visibly bent.With markers attached and fully seated, the probe displayed high geometry and divot error readings.The support arm for marker #3 was bent causing the high geometry error and the bent tip was causing the high divot error.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.Device manufacturing date is unavailable.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 that the probe had a bent tip.It was reported that the probe could verify if two spheres were removed off the bent portions of the probe.There was no patient present when this issue was identified.It was reported that the probe was part of an evaluation system and was bent upon arrival.

• 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: 9519739
• Report Number: 1723170-2019-06164
• Device Sequence Number: 16821266
• Product Code: HAW
• UDI-Device Identifier: 00673978090153
• UDI-Public: 00673978090153
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/26/2019

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: Health Professional
• Device Model Number: 960-559
• Device Catalogue Number: 960-559
• Device Lot Number: 131018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1