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

Catalog Number 9734403

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2016

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 for suspect thoracic probe.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 posterior spinal fusion procedure, the site's thoracic probe was bent.No further details regarding the damage, or how it occurred, were provided.The surgeon opted to continue and 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

Investigation of returned suspect thoracic probe was unable to replicate the reported issue.The tip of the probe does not appear to be bent.There are nicks along the edge at the tip, but no bend.There are also several small impact marks at the back end but they do not effect function.No problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: 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: 5982095
• MDR Text Key: 55788728
• Report Number: 1723170-2016-02375
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994724014
• UDI-Public: 00613994724014
• 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: 11/17/2016

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: 9734403
• Device Lot Number: 140910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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