MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL; INSTRUMENT, STEREOTAXIC

Model Number	9733065
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not populated is unavailable due to (b)(6) privacy law.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 intra/peri-operatively during the navigate task of a cranial biopsy procedure, the biopsy kit was damaged.The clear tube would not ¿snap¿ into the grey external part that is secured to the skull which enables the trajectory to be locked, and biopsy taken.The site used the angled fixation piece and were able to successfully get the biopsy.There was no delay to the procedure and there was no reported impact on patient outcome.
Additional Manufacturer Narrative
A hardware analysis was initiated to determine the probable cause of the issue.Analysis found that the guide tube did not fit easily into the base.It was a very tight fit that did not allow movement of the tube.The hardware analysis is being tracked in medtronic navigation tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8813585
• Report Number: 1723170-2019-04175
• Device Sequence Number: 11311838
• Product Code: HAW
• UDI-Device Identifier: 00613994157119
• UDI-Public: 00613994157119
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 09/12/2020
• Device Model Number: 9733065
• Device Catalogue Number: 9733065
• Device Lot Number: 066225517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1