MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® SYSTEM NAVIGATED BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1884380EM
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during functional endoscopic sinus surgery, the quadcut blades were wobbly.They started off fine but became wobbly the more they were used in the procedure, replaced one nav quadcuts with another.The new nav quadcut was wobbly from the beginning of use, eventually replaced both with a tricut non navigated.Also tried a second m4 handpiece and this did not fix the issue.The tricut blade worked perfectly.Tried the tricut blade in the first handpiece and it worked fine in both handpieces so it was determined the issue was with the blades and not the m4s.The procedure was delayed by 15 minutes and completed with backup product without any intervention.There was no patient impact.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H6: previously applied code of fdr d14 is no longer applicable.Additional code of imf f05 is no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: aware date in the previous report was incorrectly submitted.The correct aware date was 14 september 2024.Correction: h6: previously applied code of fdc d14 is no longer applicable.Correction: previously applied additional code of imf f05 is no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: XPS® SYSTEM NAVIGATED BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 17972100
• Report Number: 1045254-2023-00854
• Device Sequence Number: 17398606
• Product Code: EQJ
• UDI-Device Identifier: 00763000579272
• UDI-Public: 00763000579272
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2024

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 Expiration Date: 04/25/2025
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0226452524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 09/14/2023; 09/14/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 09/14/2024; 09/17/2024
• Date Device Manufactured: 04/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 119 KG