MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST 960-539 GUIDE BIOPSY; INSTRUMENT, STEREOTAXIC

Model Number	960-539
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was refused to be provided by the site.Device lot number, or serial number, unavailable.The instrument was not returned, so no analysis was conducted.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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 for a cranial biopsy procedure.The issue occurred intraoperatively and delayed the surgery by 5 minutes.It was reported that the site had a damaged precision aiming device and the wing would not tighten.The surgery was completed by obtaining a new articulating arm tray and there was no impact on patient outcome.
Additional Manufacturer Narrative
The lot number was provided.The udi was corrected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INST 960-539 GUIDE BIOPSY
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8214314
• Report Number: 1723170-2019-00060
• Device Sequence Number: 1987957
• Product Code: HAW
• UDI-Device Identifier: 00763000055578
• UDI-Public: 00763000055578
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

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: 960-539
• Device Catalogue Number: 960-539
• Device Lot Number: 071107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1