MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) AWL/PROBE/TAP DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number APT DRIVER

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

Device lot number not available. Device manufacturing date is dependent on lot number, therefore, unavailable. Return requested for awl/probe/tap driver. No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that, while in a spine procedure, the site's the apt driver was coming unscrewed during use. The surgeon switched to a different instrument to continue the procedure. No further details regarding the damage, or how it occurred, were provided. The surgeon completed the procedure with the use of the navigation system. There was no delay of therapy. There was no impact on patient outcome.

• Brand Name: AWL/PROBE/TAP DRIVER
• 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: 5474584
• MDR Text Key: 39526085
• Report Number: 1723170-2016-00275
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: APT DRIVER
• Device Catalogue Number: 963-799
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/03/2016
• 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