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

Model Number	1884006HR
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: visually, the pouch was open from 3 of 4 sides when returned.There were traces of contamination found inside the pouch, on the outer tube (in the bent area of the tube), and at the proximal end/tip of the inner cutter.The device and an open pouch were returned in a resealable bag.There was no packaging carton nor inserts returned with the device.There was no damage noted to the outer tube or the hubs.However, there was a gap noted between the inner cutter tip and the middle tube tip.Functionally, the inner and middle assemblies spun by hand and there was no binding observed.During the blade oscillation up to 7,500rpm, there was an unusual noise observed.The inner cutter tip was oscillating while middle tube tip was slightly moving/wobbling.For further analysis, an x-ray was performed to capture the internal components of the device, and it was observed that the inner and middle tube assembly spiral wrap was expanded/stretched.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint.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 there was no noticeable break when the blade was inserted to the handpiece, but when the surgeon started to use it, there was an unusual sound it created and the blade wasn't doing what it was supposed to do, like debriding.The inner blade was broken but there were no broken parts or pieces detached from the blade.It was replaced with a new one as it wasn't usable at all.There was no patient impact.

• 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: 21289646
• Report Number: 1045254-2025-00234
• Device Sequence Number: 9320252
• Product Code: EQJ
• UDI-Device Identifier: 00763000518325
• UDI-Public: 00763000518325
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/01/2025

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: 1884006HR
• Device Catalogue Number: 1884006HR
• Device Lot Number: 0229655127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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