MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC ACTIVE CRANIAL REFERENCE FRAME; INSTRUMENT, STEREOTAXIC

Model Number	9733881
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while in a tumorectomy, the navigation system could not recognize the cranial active reference frame being used in the procedure.The surgeon opted to complete the procedure without the use of the navigation system.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.Following the procedure, it was reported that the issue could be replicated on the reference frame in question as a recognition failure occurred in both sterile and non-sterile fields.It was noted that a separate cranial reference frame could be tracked by the navigation system during troubleshooting.No additional information was provided.
Additional Manufacturer Narrative
Analysis of the returned cranial reference frame found no anomaly.When connected to a known good system, the reference frame was found to be fully functional displaying good geometry and divot error readings with normal tracking and all leds.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVE CRANIAL REFERENCE FRAME
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8387201
• Report Number: 1723170-2019-00899
• Device Sequence Number: 13960686
• Product Code: HAW
• UDI-Device Identifier: 00643169545588
• UDI-Public: 00643169545588
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• 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): 08/23/2019

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: 9733881
• Device Catalogue Number: 9733881
• Device Lot Number: 170619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1