MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 2.25 MM PEDICLE PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733457

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Return requested.Replacement pedicle probe 2.25mm shipped to site.No parts have been received by manufacturer for analysis.No further issues have been reported.Part not received by manufacturer.

Event Description

A medtronic representative reported that, while in a spine procedure, the surgeon alleged there was an error of the pedicle probe.The staff of the hospital inspected the probe and found that the tip of the probe was slightly bent.After the registration, the surgeon suspected that there was an inaccuracy.The tip of the probe was found to be slightly bent.The pedicle probe was replaced with a back-up pedicle probe, and the a back-up probe worked normally, without issue.The navigation system allowed them to verify the instrument.The surgeon used the pointer to check the location, instead of the probe.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

Manufacturer Narrative

Device lot number now provided.Device manufacturing date now provided.Investigation of returned suspect probe finds that as reported, the tip of the probe is slightly bent.However, with markers attached and fully seated, the probe returned good geometry and divot error readings.The probe is fully functional.The reported issue was confirmed to be caused by physical damage of the instrument tip.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: 2.25 MM PEDICLE PROBE
• Type of Device: NEUROLOGICAL 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: 5596413
• MDR Text Key: 43281048
• Report Number: 1723170-2016-00602
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• 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: 11/21/2016

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: 9733457
• Device Lot Number: 140818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• 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