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

Catalog Number 9732520

Device Problems Mechanical Problem (1384); Material Deformation (2976); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  malfunction  

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 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
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6134085
• MDR Text Key: 61088452
• Report Number: 1723170-2016-05472
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994123565
• UDI-Public: 00613994123565
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Catalogue Number: 9732520
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1