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

Catalog Number	9734403
Medical Device Problem Codes	Bent (1059); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 5982095
• Report Number: 1723170-2016-02375
• Device Sequence Number: 13831631
• Product Code: OLO
• UDI-Device Identifier: 00613994724014
• UDI-Public: 00613994724014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1