MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) IMAGE GUIDED HANDLE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9731110
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the onsite inspection, the medtronic representative reported that the issue was able to be reproduced.The medtronic representative also notified the site that they should not use an instrument if it does not verify.The instructions for use (ifu) which accompanies this device contains the following warnings regarding instrument verification: "warning: physically inspect instruments for any defects.Never attempt to use a bent or damaged instrument." and contains troubleshooting steps when instruments fail verification.The medtronic representative was able to replicate the issue and has taken the unilateral handle out of circulation.The site declined to return the unilateral handle, however, the surgeon stated that since it wouldn't be replaced it would be removed from circulation.Since the part will not be returned, no further analysis is possible.A successful system checkout was also performed.
Event or Problem Description
A medtronic representative reported during a case that the site was unable to verify the osteotome on the unilateral handle.The surgeon manipulated the part, against user instructions, and was then able to navigate successfully.There was no impact to the patient reported and a 10 minute delay in the surgery.

• Brand Name: IMAGE GUIDED HANDLE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6276148
• Report Number: 1723170-2017-00306
• Device Sequence Number: 1477510
• Product Code: HAW
• UDI-Device Identifier: 00885074102641
• UDI-Public: 00885074102641
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K012937
• 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
• Type of Report: Initial
• Report Date (Section B): 01/25/2017

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 9731110
• Device Lot Number: 090605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2016
• Initial Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 82