MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BASE, 9732520, QUICK RELEASE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9732520
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not made available from the site.Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Return requested for suspect quick release base.No parts have been received by manufacturer for analysis.
Event or Problem Description
A medtronic representative reported that, during preparation for a spine procedure, the surgeon alleged an issue with their quick release base.Reported was that a fixation pin was put through the quick release base.While an attempt was made to implant a drill(s), gauze was interfering.A back-up product was used to continue the procedure instead.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy reported.There was no impact on patient outcome.

• Brand Name: BASE, 9732520, QUICK RELEASE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6134085
• Report Number: 1723170-2016-05472
• Device Sequence Number: 16432827
• Product Code: HAW
• UDI-Device Identifier: 00613994123565
• UDI-Public: 00613994123565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/29/2016

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: 9732520
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1