MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV THORACIC PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734680

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement thoracic probe shipped to site 04/05/2016.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a spine procedure, the site's straight thoracic probe tip was bent.No further details regarding the damage, or how it occurred, were provided.The procedure was continued using a second probe.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was 30 minutes.There was no impact on patient outcome.

Manufacturer Narrative

(b)(4).Medtronic investigation of returned suspect thoracic probe finds that the tip of the probe was slightly bent, and a small nick at the tip.Testing also found impact marks at the back end of the probe.The fit with the navlock tracker was difficult as well.The hardware investigation found that the reported event was related to a hardware issue.The reported event was confirmed to be caused by physical damage.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: NAV THORACIC PROBE TIP
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5624797
• MDR Text Key: 44367470
• Report Number: 1723170-2016-00668
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K124004
• 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,Followup
• Report Date: 06/01/2016

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: 9734680
• Device Lot Number: 111021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2011
• 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: 50 YR