MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK UNIVERSAL GREY TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734590
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available from the site.The device was not returned, so no analysis has been conducted.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively during the navigate task and caused no delay to the surgery.It was reported that the navlock was damaged during the case.They were malletting the handle and one of the clips began to pop out.They were able to hit it back into place.The surgery was completed with navigation and there was no impact on patient outcome.
Additional Manufacturer Narrative
The grey navlock tracker was returned to the manufacturer for analysis.Analysis found that one of the two side tabs has been impacted and is slightly bent causing it to rub at the tip.This creates a clicking noise and interferes with the movement of an inserted instrument.Otherwise, with markers attached and fully seated, the tracker returns good geometry and divot error readings.Analysis found that the reported event was related to physical damage.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: NAVLOCK UNIVERSAL GREY TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8641683
• Report Number: 1723170-2019-02636
• Device Sequence Number: 14119142
• Product Code: OLO
• UDI-Device Identifier: 00763000209551
• UDI-Public: 00763000209551
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/17/2019

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: 9734590
• Device Catalogue Number: 9734590
• Device Lot Number: 121108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 59