MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC DRIVER 9734228 GRAY ASSY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734228
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The driver was returned to the manufacturer for analysis.Analysis found that the post on one of the support arms of the driver was missing.Otherwise, with the remaining markers attached and fully seated, the driver returned good geometry and divot error readings.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 device being used outside a procedure.It was reported that the gray navlock driver was damaged.There was no patient present when this issue was identified.

• Brand Name: DRIVER 9734228 GRAY ASSY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8201770
• Report Number: 1723170-2018-06479
• Device Sequence Number: 2279946
• Product Code: OLO
• UDI-Device Identifier: 00613994671820
• UDI-Public: 00613994671820
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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: Health Professional
• Device Model Number: 9734228
• Device Catalogue Number: 9734228
• Device Lot Number: 170302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1