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 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Return requested.Replacement thoracic probe shipped to site 01/20/2017.Medtronic investigation of returned suspect thoracic probe finds that the tip of the thoracic probe was twisted.Reported issue confirmed.Bent instrument tip.Failure: physical damage.Hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.

Event Description

A medtronic representative received a report from a site that while in a t10-l2 fusion spine procedure, the thoracic probe was being used, the tip became visibly 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 reported.There was no impact on patient outcome.

Manufacturer Narrative

Patient demographics provided.

Manufacturer Narrative

There was a reported delay to the procedure of less than 1 hour due to this issue.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6329142
• MDR Text Key: 67441476
• Report Number: 1723170-2017-00742
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994870063
• UDI-Public: 00613994870063
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

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: 160920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided; 06/07/2017
• Supplement Dates FDA Received: 03/28/2017; 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• 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
• Patient Age: 62 YR
• Patient Weight: 76