MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRACKER KIT 9734914 NAVLOCK UNIV GRE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734914

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter unavailable from the site at the time of filing.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.A representative went to the site to test the instrument and was unable to replicate the issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the site was alleging issues related to minor inaccuracies that they believed to stem from their 3 navlocks.There was no reported patient present when this issue was reported.

Manufacturer Narrative

Additional information was received.The issue was thought to be caused by the navlock not seated correctly on the instrument after hammering the back end of the navlock.Representatives have been in cases with the system and instruments since the event and the issue has not occurred.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRACKER KIT 9734914 NAVLOCK UNIV GRE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8161533
• MDR Text Key: 130266620
• Report Number: 1723170-2018-06242
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9734914
• Device Catalogue Number: 9734914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1