MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SMALL ACTIVE CRANIAL FRAME LONG CABLE; INSTRUMENT, STEREOTAXIC

Model Number	9733881
Medical Device Problem Codes	Material Integrity Problem (2978); Output Problem (3005)
Health Effect - Clinical Codes	Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned to the manufacturer for analysis.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 procedure.The information received was contradicting and we are following up to confirm the information.It was reported that one of the led lights had a recognition failure.The procedure was completed with the continuous use of the frame.The site was able to complete the procedure with the use of the frame.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Analysis on the returned active frame resulted in an electrical failure being found through functional testing and visual/physical examination.Analysis states that, when connected to a known good system, it was found that led #3 was not firing.Otherwise, the frame returned good geometry and divot error readings.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient information was unavailable.Additional information: updated event description.Additional information: fda patient code has been updated to proper value.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was clarified that this issue occurred during a craniotomy procedure.It was noted that the active reference frame could be used for the time being even though one led did not recognize.There was no surgical delay due to this issue.There was no known or reported impact on patient outcome.

• Brand Name: SMALL ACTIVE CRANIAL FRAME LONG CABLE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8175256
• Report Number: 1723170-2018-06336
• Device Sequence Number: 1626366
• Product Code: HAW
• UDI-Device Identifier: 00613994480637
• UDI-Public: 00613994480637
• 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,Followup
• Report Date (Section B): 02/11/2019

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: 140812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 02/11/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/15/2019; 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1