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

Catalog Number	9734403
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect thoracic probe has been received by manufacturer for evaluation.Testing found that the tip of the probe had nicks and was bent to one side.The back end of the probe had several impact marks not allowing the probe to insert into the mating navlock tracker.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.
Event or Problem Description
A medtronic representative reported that during a spinal fusion procedure while in navigation when using the thoracic probe to start entry point in the bone the tip of the probe bent.The surgeon completed the procedure with another probe.The procedure was completed with the use of navigation.There was a delay of less than 1 hour.No impact on patient outcome.
Additional Manufacturer Narrative
Correction: unique device identification (udi) updated to proper value.

• 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: 6887420
• Report Number: 1723170-2017-03876
• Device Sequence Number: 16267534
• Product Code: OLO
• UDI-Device Identifier: 00763000053796
• UDI-Public: 00763000053796
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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
• Operator of Device: Physician
• Device Catalogue Number: 9734403
• Device Lot Number: 100323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1