MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAVLOCK TRACKER UNIVERSAL ORANGE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 160523

Device Problems Mechanical Problem (1384); Device Inoperable (1663); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not made available from the site.Return requested.Replacement navlock universal orange tracker shipped to site 10/19/2016.Medtronic investigation of returned suspect navlock universal orange tracker finds that when the tracer was tested with known good tools, determined to have slight binding when tool was inserted approximately halfway into the tracker.Visual inspection found a line of galling that would contribute to the binding.Once tool was fully inserted, it would rotate freely.Confirmed mechanical failure.

Event Description

A medtronic representative reported that, while in a spine transforaminal lumbar interbody fusion (tlif) procedure, when using the navlock with the powerease, the navlock tracker would not rotate freely and appeared bound to the probe.A second navlock was brought in to use to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

Additional information :patient identifier provided.

Manufacturer Narrative

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: NAVLOCK TRACKER UNIVERSAL ORANGE
• Type of Device: ORTHOPEDIC 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: peter verhey ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6095052
• MDR Text Key: 59888660
• Report Number: 1723170-2016-02826
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 160523
• Device Catalogue Number: 9734683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• 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
• Patient Age: 70 YR
• Patient Weight: 108