MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STRAIGHT SUCTION, AXIEM; INSTRUMENT, STEREOTAXIC

Model Number	9733449
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is conflicting information in this file that the patient was (b)(6) years old at the time of the issue, however, the date of birth that was provided was (b)(6).Follow-up is being conducted for clarification.The straight suction was returned to the manufacturer for analysis.Analysis found that the suction was unable to be verified when attached to a known good tracker.It returned a divot error of 2.2 millimeters.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess).It was reported that intra-operatively, it was difficult to verify two bent straight suctions.The suctions were tested outside of a case in a demo environment and were both getting a 1.8 error metric.The procedure was completed using the navigation system and a malleable suction.There was no reported impact to patient outcome and there was a one minute delay due to this issue.One of the instruments was tested the following day and verified with some difficulty.It was reading a 2.0 geometry error when it verified.The other instrument was used in a case, but never verified.There was conflicting information as this issue was initially reported to have occurred outside of a procedure.However, additional information was received that this issue occurred during a procedure.Follow-up is being conducted for clarification on the issue.
Additional Manufacturer Narrative
Correction: initial report indicated that the straight suction returned a divot error of 2.2 millimeters.Should have stated that the straight suction returned a divot error of 2.2 millimeters to 2.3 millimeters.Additional information: this is conflicting information from the initial report of the event.Further follow-up is being conducted.Further analysis was performed on the two returned straight suctions.Both failed divot testing.One straight suction was visibly bent and failed with a divot error of 2.1.The second straight suction was not bent and failed with a divot error of 2.5.This complaint is for one straight suction.1723170-2019-00313 for other straight suction.
Event or Problem Description
Medtronic received additional information that the straight suctions were not physically bent.The straight suction would not verify.The straight suctions were not used during the procedure or any procedures after the reported issue.The issue was found outside of the procedure.
Additional Manufacturer Narrative
Additional analysis was performed on the unbent straight suction and confirmed that the tip location was out of specification.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that the date of birth provided in the initial report was the correct date of birth.Medtronic also received confirmation that the issue initially occurred in a procedure and when tested outside of the procedure.

• Brand Name: STRAIGHT SUCTION, AXIEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8258012
• Report Number: 1723170-2019-00312
• Device Sequence Number: 16721242
• Product Code: HAW
• UDI-Device Identifier: 00643169702851
• UDI-Public: 00643169702851
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/02/2019

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 Model Number: 9733449
• Device Catalogue Number: 9733449
• Device Lot Number: 180417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 01/17/2019; 02/14/2019; 04/12/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/14/2019; 03/13/2019; 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 84