MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AWL SHARP; 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	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.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 before a procedure the probe had difficulty attaching to the tracker.The manufacturer representative swapped out the trackers and saw that the same behavior with each tracker/probe combination.No patient was present at the time of the event.

• Brand Name: AWL SHARP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8513499
• Report Number: 1723170-2019-01738
• Device Sequence Number: 11193530
• Product Code: OLO
• UDI-Device Identifier: 00613994870049
• UDI-Public: 00613994870049
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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: 9734678
• Device Catalogue Number: 9734678
• Device Lot Number: 160420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1