MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PASSIVE PLANAR PROBE; INSTRUMENT, STEREOTAXIC

Model Number 960-556

Device Problem Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The probe was returned and analyzed.The tip of the probe was confirmed to be visibly bent.With markers attached and fully seated, the probe displayed good geometry and divot error reading with normal tracking.Codes 10, 180 and 4307 are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system that was used outside of procedure.It was reported that the site has a damaged passive planar probe instrument.The probe is bent at the tip.No patient present.Additional information was received.It was reported that the surgeon discovered this prior to the procedure and there was no patient present.The cause of the damage was unknown.

• Brand Name: PASSIVE PLANAR PROBE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 10160803
• MDR Text Key: 195381304
• Report Number: 1723170-2020-01673
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00673978090122
• UDI-Public: 00673978090122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 960-556
• Device Catalogue Number: 960-556
• Device Lot Number: 130313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1