MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PASSIVE BIOPSY NEEDLE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733068
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The needle was returned for product analysis.The returned biopsy needle had been bent.Not able to test for functionality.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a cranial biopsy.It was reported that during a biopsy the user locked the trajectory and when they went to pass the needle, the needle would not track.They had the guide stem and correct reducing tube in place.The spheres were clean and dry and there was no visible damage.The manufacturer representative offered to open a new needle for the surgeon but the surgeon decided to not track the needled instead of opening another one.They felt confident that the system would guide the needle correctly.The surgeon completed the procedure and they did get diagnostic results back.The issue was resolved on call.There was no delay to the procedure and no impact on patient outcome.

• Brand Name: PASSIVE BIOPSY NEEDLE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12738357
• Report Number: 1723170-2021-02615
• Device Sequence Number: 4238350
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: 00643169702943
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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: 12/30/2022
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066536520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 95