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

Model Number	1884016HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device, tyvek envelope, and an open pouch were returned in a resealable bag.The pouch was open from 3 of 4 sides and the open sides of the pouch were stapled when returned.There were traces of contamination observed on the returned device.It was also observed that the middle tube spiral wrap (distal end) was expanded and passed the distal end of the outer tube by approximately 0.04 inches.There was a gap between inner and middle tube tips observed as well.The inner and middle tube assemblies could hardly spin by hand; there was a resistance and binding.The device was loaded easily into a handpiece and while oscillating up to 5,000 rpm, it was observed that the inner shaft tip was moving in up/down mode, not spinning properly.For further analysis, an x-ray was performed to capture internal components of the device, and it was observed that the middle tube spiral wrap was expanded and some of the vertebrates on the middle tube spiral wrap were broken.The device failed functional testing due to defective conditions upon return and the inability to spin properly.The complaint was confirmed, due to an out of specification condition.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 operation; blade was reported to have the front tip protrude.The procedure was completed with backup product.There was no patient impact in this event.

• 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: 22836315
• Report Number: 1045254-2025-01995
• Device Sequence Number: 21183208
• Product Code: EQJ
• UDI-Device Identifier: 00763000518349
• UDI-Public: (01)00763000518349(17)290113(10)0230468118
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: 1884016HR
• Device Catalogue Number: 1884016HR
• Device Lot Number: 0230468118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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