MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SOLERA DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9735281
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	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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" (september 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 screwdriver being used in the procedure was damaged.The representative noted that the instrument broke and that none of the instrument fell into the patient's anatomy.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.
Additional Manufacturer Narrative
Additional information: device lot number and manufacture date provided.The suspect driver was returned to the manufacturer for evaluation.The driver was found to have the tip broken off.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.

• Brand Name: SOLERA DRIVER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6907421
• Report Number: 1723170-2017-03983
• Device Sequence Number: 16396765
• Product Code: OLO
• UDI-Device Identifier: 00643169340626
• UDI-Public: 00643169340626
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Relabeling,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 9735281
• Device Lot Number: 130626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 136