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	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, after mounting the blade on the microdebrider strainghshot m5, testing the operation of the handpiece the hcp noticed that the terminal part of the blade, due to oscillation of the motor, vibrated consistenly.Firstly they tried to reinsert the blade (but was firmly and correctly mounted), then to change the blade thinking to a defective product but also the second blade showed the same movement.After, they tried to change the handpiece to avoid that the issue was caused by a malfunctioning debrider but the problem occurred also with the second handpiece.Lastly they change the blade using another pack of the same model and everything worked properly.There was no patient involved in the event.
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.
Additional Manufacturer Narrative
H6: fdc d16 code no longer apply.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
H3: analysis found that visually, the pouch was open from 2 of 4 sides when returned.There was no external damage noted in the construction of the returned device.Functionally, the inner assembly spun easily by hand with no binding.The device was securely locked into a handpiece and ran up to 7,500rpm in oscillating mode.During the blade oscillation an excessive wobbling was observed.For further analysis, the inner assembly was pulled out of the outer assembly, and it was noticed that the inner shaft was bent near the distal end of the inner hub.The device failed due to defective condition upon return and the inability to spin properly.H6: fdm b17, fdr c20 and img g04041 codes no longer apply.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® 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: 20046739
• Report Number: 1045254-2024-01318
• Device Sequence Number: 18126051
• Product Code: EQJ
• UDI-Device Identifier: 00613994779182
• UDI-Public: 00613994779182
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup,Followup
• Report Date (Section B): 03/06/2025

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: 0229007550
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 12/26/2024; 02/10/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 12/27/2024; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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