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 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to japanese patient privacy regulations.Device lot number unavailable.Device manufacturing date is dependent on lot number therefore, unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation device being used for a posterior spinal fusion surgery procedure.The issue was noted intra-perioperatively and had no impact on the patient outcome.There was no delay in surgery.It was reported that during the procedure, the thoracic probe tip was bent and that led to navigation being inaccurate.The inaccuracy was confirmed by the representative to be 3mm with no direction specified.The inaccuracy occurred when the last screw was placed and not when the probe was used.The procedure was completed with the use of the navigation system without further issue.

Manufacturer Narrative

Additional information: lot number and device manufacture date provided.

Manufacturer Narrative

The probe was returned to the manufacturer for evaluation.Testing found that the tip of the probe was bent to one side.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: 7559035
• MDR Text Key: 109744782
• Report Number: 1723170-2018-02375
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2018

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: 160830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 06/01/2018; 08/07/2018
• Supplement Dates FDA Received: 06/24/2018; 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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