MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 70 DEG CURVED SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9733450
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The site declined to provide patient information, per (b)(4) privacy laws.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.A medtronic representative, following-up at the site, reported both suctions verified successfully without manipulation, and within a few seconds, however, were inaccurate by approximately 4 millimeters s/i and 2 millimeters a/p.All other instruments, including curved suctions from another tray, were accurate.The surgeon stopped using these instruments, and continued the procedure with minimal delay and no patient impact.On 11/15/2016, a medtronic representative performed a navigation system check-out, software and hardware areas passed.Instruments test failed.Curved suctions were several millimeters inaccurate.Items will need to be replaced.Recommended instrument replacement.Issue resolved.System performed as intended.It was reported that the suctions that were inaccurate were accidentally sent through the incorrect sterilization process by the site, because of this error, the suctions, became damaged.The site has been made aware and will replace the suctions.Return requested for curved suction 70 and curved suction 90 on 11/17/2016.No parts have been received by manufacturer for analysis.No further issues have been reported.
Event or Problem Description
A medtronic representative reported that, while in a functional endoscopic sinus surgery (fess), the surgeon alleged an inaccuracy occurred.The surgeon alleged a 4 millimeter inaccuracy with the curved 70 degree suction.All other instruments were accurate within 0.5 millimeters.Suction verified with no issue, however, the surgeon deemed being inaccurate using them.The doctor stopped using these instruments and continued the procedure.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
Additional Manufacturer Narrative
Correction to event date now provided.Correction to aware date now provided on initial mdr submitted: 11/15/2016.Additional information: although a specific cause of the reported incident was unconfirmed as the part was not received to the manufacturer, an investigation into returned parts with similar reported malfunctions was completed via capa investigations.
Additional Manufacturer Narrative
Additional information: device lot number and manufacture date provided.

• Brand Name: 70 DEG CURVED SUCTION, AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6175743
• Report Number: 1723170-2016-05764
• Device Sequence Number: 16246676
• Product Code: HAW
• UDI-Device Identifier: 00613994378477
• UDI-Public: 00613994378477
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2017

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: 9733450
• Device Lot Number: 16030143
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 04/13/2017; 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1