MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC THORACIC PROBE NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734680
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was returned to medtronic for analysis.Analysis confirmed the reported issue.The tip of the returned probe was twisted.There were also impact marks at the back end causing fit issues with any mating 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure.It was reported that the surgeon bent a thoracic probe during a case.It was unknown if the probe was still able to verify after the damage.A different probe was used to complete the procedure.There was a less than 1 hour delay to the procedure and no impact to patient outcome.

• Brand Name: THORACIC PROBE NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9922086
• Report Number: 1723170-2020-01151
• Device Sequence Number: 3131353
• Product Code: OLO
• UDI-Device Identifier: 00763000054205
• UDI-Public: 00763000054205
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: No Information
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 191219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 119