MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV CD HORIZON SOLERA MAST 4.75 DRIVER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9734856
Medical Device Problem Codes	Device Inoperable (1663); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Return requested.Replacement device shipped to site (b)(4) 2016.No parts have been received by manufacturer for analysis.
Event or Problem Description
A site representative reported that their solera screwdriver was defective and unusable.The head of the driver is worn and the driver turns around without gripping the implant.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Investigation of returned suspect driver finds that the returned screwdriver was found to be in good condition.The tip is intact and fully engages with a mating screw.The back end has no apparent damage and inserts into a known good navlock without issue.No problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: NAV CD HORIZON SOLERA MAST 4.75 DRIVER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 5992060
• Report Number: 1723170-2016-02457
• Device Sequence Number: 10783904
• Product Code: HAW
• UDI-Device Identifier: 00643169045040
• UDI-Public: 00643169045040
• Combination Product (Y/N): N
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2016

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 Catalogue Number: 9734856
• Device Lot Number: 120430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1