MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STRAIGHT SUCTION; 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	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The straight suction has been returned to medtronic, however, analysis has not been completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used intra/peri-operatively of a functional endoscopic sinus surgery (fess) procedure.It was reported that the straight suction had difficulty verifying.The surgeon ended up having to rotate the suction to the left before it would verify.The issue was able to be replicated by a manufacturing representative.There was a less than 1-hour delay to the procedure and no impact on patient outcome.
Additional Manufacturer Narrative
Analysis on the returned straight suction had issues verifying when attached to a known good tracker returning a divot error of 1.9 to 2.1 mm.The failure was found through functional testing and visual/physical examination.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRAIGHT SUCTION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8970781
• Report Number: 1723170-2019-04785
• Device Sequence Number: 2883615
• Product Code: HAW
• UDI-Device Identifier: 00613994378422
• UDI-Public: 00613994378422
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/08/2019

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: 31018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 73