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

Catalog Number	9734913
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Lot no.And manufacture date not available for this instrument at time of filing.No parts have been returned to the manufacturer for evaluation.
Event or Problem Description
Medtronic received information that, while outside of a procedure, the thoracic probe for the site was bent.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device lot number provided.The probe was returned to the manufacturer for evaluation.Testing found that the tip of the probe was not bent.However, it was noted that impact marks at the back end led to fit issues with trackers.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.
Additional Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided.

• Brand Name: INST KIT PROBE THORACIC ASSY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7575254
• Report Number: 1723170-2018-02550
• Device Sequence Number: 13989260
• Product Code: OLO
• UDI-Device Identifier: 00643169636095
• UDI-Public: 00643169636095
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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: 9734913
• Device Lot Number: 170606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 08/07/2018; 08/28/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/28/2018; 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1