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

Model Number	1884380HR
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during set up the blade wobbled when activated, seems insecure with the microdebrider handle.The handpiece was the component that was vibrating and caused the blade to wobble.The vibrating device was not used on the patient.The procedure was completed with another blade.There was no patient impact.
Additional Manufacturer Narrative
B5: additional information has been updated.H3: product analysis found that the device and an open pouch were returned in a resealable bag.The pouch was open from 3 of 4 sides when returned.There were traces of contamination observed at the distal end of the outer tube.It was also observed that the sides of the distal end of the inner hub were uneven.The inner assembly spun by hand with no binding sound observed.The device was loaded into a handpiece and ran in oscillating mode up to 7 ,500rpm.During the functional testing there was an excessive wobbling observed.For further analysis, the inner assembly was pulled out of the outer assembly, and it was observed that the area of the inner shaft located near the distal end of the inner hub was bent.The device failed functional testing due to defective condition upon return and the inability to rotate properly.The complaint was confirmed, due to an out of specification condition.H6: codes b01, c070601, c070605, d1102 and g04112 has been updated.The previously updated codes b17, c20 and d16 were no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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.
Event or Problem Description
Additional information stated that the "wobbling" issue was isolated to the original blade; the microdebrider worked properly with a new blade.

• Brand Name: XPS® 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: 23023658
• Report Number: 1045254-2025-02123
• Device Sequence Number: 9329526
• Product Code: EQJ
• UDI-Device Identifier: 00613994779182
• UDI-Public: (01)00613994779182(17)280623(10)0229147517
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 10/06/2025

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: 1884380HR
• Device Catalogue Number: 1884380HR
• Device Lot Number: 0229147517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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 Sex: Unknown