MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Unintended Arm Motion (1033); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.Return requested.Replacement articulating arm shipped to site 12/06/2016.No parts have been received by manufacturer for analysis.Part not received by manufacturer.

Event Description

A site representative reported their navigation system articulating arm would not tighten properly.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

Suspect vertek arm was returned and evaluated: the returned arm is a down revision part.The instrument end does not lock down when the handle has been tightened.The instrument end appears to have been tampered with.There are tool marks and brush marks.This end is loose.The handle is also loose and has an extra washer added.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: STEALTHSTATION S7 SYSTEM
• 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 6227579
• MDR Text Key: 64011906
• Report Number: 1723170-2017-00038
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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