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 Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.This device is included in the medical device field correction notification, "potential for instrument breaking ¿ medtronic navigated solera screwdrivers" ((b)(6) 2015).The revised instructions for use (ifu) were also provided with the notification.
Event or Problem Description
A medtronic representative reported that, while in a spinal fusion, the screw driver for the procedure became sheared.The shearing was reported to have been caused by the bone density of the patient and the torque required to insert the screw.The site elected to complete the procedure with a separate instrument.No additional information was provided.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.Two screwdrivers were reported to be damaged during the procedure, the first is documented under filing number 1723170-2017-01415.
Additional Manufacturer Narrative
Additional information: patient id, date of birth and gender provided.

• 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: 6447435
• Report Number: 1723170-2017-01416
• Device Sequence Number: 996782
• Product Code: HAW
• UDI-Device Identifier: 00643169045040
• UDI-Public: 00643169045040
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Relabeling,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: Physician
• Device Catalogue Number: 9734856
• Device Lot Number: 130524
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2823/2824-2015
• Patient Sequence Number: 1
• Patient Age: 68 YR