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 Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Lot no., udi and manufacture date not available for this instrument at time of filing.A system checkout was not required as resolution of the issue was confirmed at the time of the event.Part not returned.

Event Description

Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively while navigating and caused no delay to surgery.It was reported that the tip of the thoracic probe was bent during the surgery.The surgeon completed the surgery with the thoracic probe and navigation.There was no impact on patient outcome.

Manufacturer Narrative

Additional information: device lot number, unique device identification (udi) and manufacture date provided.The probe was returned to the manufacturer for evaluation.Testing found that the tip of the probe was twisted and there were impact marks noted on the back end of the probe, resulting in fit issues.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: 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7587368
• MDR Text Key: 110632838
• Report Number: 1723170-2018-02646
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734680
• Device Lot Number: 170829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• 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