MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PROBE 9734403 THORACIC; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734403
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The instrument was returned for analysis.Functional testing found galling causing mating issue with the tracker.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 of a procedure.It was reported that there was an issue with one of the site's navlock.The instrument was not accepting any instruments and also damaged two other instruments.It left grooves in the metal which prevents them from sliding into the shaft correctly.

• Brand Name: PROBE 9734403 THORACIC
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8384023
• Report Number: 1723170-2019-00862
• Device Sequence Number: 19340262
• Product Code: OLO
• UDI-Device Identifier: 00613994724014
• UDI-Public: 00613994724014
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 9734403
• Device Catalogue Number: 9734403
• Device Lot Number: 180418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1