MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIOPSY NEEDLE KIT, PASSIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733068
Medical Device Problem Codes	Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier not available from the site.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Field clinical specialist was onsite providing surgical support when the reported event occurred.The biopsy needle was returned to manufacturer for analysis.No further issues were reported.Analysis of the returned needle could not confirm any failure as it tracked as expected when placed into the reducing tube with the plan locked.No problem found.
Event or Problem Description
A medtronic representative reported that while in a cranial biopsy procedure, the biopsy needle was not seen by the navigation system.They confirmed that the trajectory was locked with nobody was touching the instrument.They also confirmed that the biopsy needle was selected for the procedure.Repeated locking procedure with no resolution.The surgeon proceeded without navigation and was able to retrieve 2 viable specimens for pathology.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
A medtronic representative went to the site to test the navigation system used alongside the suspect biopsy needle.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

• Brand Name: BIOPSY NEEDLE KIT, PASSIVE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6461206
• Report Number: 1723170-2017-01502
• Device Sequence Number: 10910543
• Product Code: HAW
• UDI-Device Identifier: 00643169546820
• UDI-Public: 00643169546820
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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: Physician
• Device Catalogue Number: 9733068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/01/2017
• 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