MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FRAME 9733886 SMALL ACTIVE HC; INSTRUMENT, STEREOTAXIC

Model Number	9733886
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the frame 9733886 small active hc (lot #: 160309) found a damaged tool.When connected to a known good system, it was found that leds #2 and #4 were not firing.Product event summary: #matters s7 recognition failure of led reference frame product analysis: (b)(4): mnav findings and conclusions: when connected to a known good system it was found that leds #2 and #4 were not firing.Mnav methodology: functional testing;visual/physical examination.Mnav usability: false.Mnav able to duplicate the issue?: yes.Mnav bai/oobf?: false.Mnav failure mode: electrical.Mnav failure mechanism: malfunction, led.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system event having occurred intra-operatively of a procedure.It was reported that the led small active reference frame had a recognition failure during the case.It was stated they were able to complete the case with navigation.No further information regarding the procedure provided.No reported impact to patient and less than an hour of delay reported.

• Brand Name: FRAME 9733886 SMALL ACTIVE HC
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8661246
• Report Number: 1723170-2019-02835
• Device Sequence Number: 13985893
• Product Code: HAW
• UDI-Device Identifier: 00643169545601
• UDI-Public: 00643169545601
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2019

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: 9733886
• Device Catalogue Number: 9733886
• Device Lot Number: 160309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 06/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1