MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAV THORACIC PROBE TIP; 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	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been returned to the manufacturer for analysis.Initial reporter unknown at the time of this report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding navigation devices used for sacroiliac and thoracolumbar procedures.It was reported that three probes were all damaged in the same spot.It was noted that the clinical details of the cases were unknown by the site and that the site used a mallet on the instruments.There was a less than hour surgical delay and no reported impact on patient outcome.
Additional Manufacturer Narrative
Additional information was received and reporter section has been updated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The thoracic probe 9734680 navlock (lot# 190516) was returned for analysis.Analysis found that the returned probe had several impact marks at the back end causing the reported fit issues with the 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.

• Brand Name: NAV THORACIC PROBE TIP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9371954
• Report Number: 1723170-2019-05773
• Device Sequence Number: 19414666
• Product Code: OLO
• UDI-Device Identifier: 00763000054205
• UDI-Public: 00763000054205
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2020

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: 190516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/02/2019; 01/30/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/17/2019; 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1