MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AWL SHARP NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734678
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The navlock was returned to the manufacture for evaluation.After visual/physical examination the reported issue was confirmed.The returned awl had impact marks at the back end causing fit issues with any mating tracker.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that the instrument seemed to be bent and doesn't fit into the navlock tracker.No patient was present at the time of the event.

• Brand Name: AWL SHARP NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10196883
• Report Number: 1723170-2020-01765
• Device Sequence Number: 14069468
• Product Code: OLO
• UDI-Device Identifier: 00613994870049
• UDI-Public: 00613994870049
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: 9734678
• Device Catalogue Number: 9734678
• Device Lot Number: 161018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1