MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 4MM 11CM LONG; BUR, EAR, NOSE AND THROAT

Model Number	1884004
Medical Device Problem Codes	Vibration (1674); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis found that visually, the pouch was open from 3 of 4 sides when returned.There was no damage noted to the tubing set, clamps, clip nor stylette.However, the outer tube was slightly bent near the distal end of the outer hub.The distal end of the inner hub was damaged and had indentions.The proximal end of the inner shaft was also damaged when returned.Functionally, the inner assembly spun by hand with sense of binding.The device was loaded into a handpiece, and while rotating in oscillating mode up to 7,500 rpm, the excessive wobbling and unusual noise were 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.There were also striations noted at the distal end/tip of the inner shaft, and on the shaft near the distal end of the inner hub.Additionally, the inner cutter tip outside diameter shall measure.1330+.000/-.0010 inches and measured.1329 inches.The device failed due to defective condition upon return and the inability to spin properly.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 endoscopic nasal polypectomy procedure, after the blade was connected to the handpiece, stepped on the pedal and it was found that the rotational speed was low and abnormal.After inspection, it was found that there was friction between the inner and outer blades of the blade, which was not flexible and caused the rotation speed to be very slow.After replacing it with a new blade, the rotation speed was normal and the operation continued.There was no allegation with the four packs.There was no patient impact.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 11CM LONG
• 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: 21442937
• Report Number: 1045254-2025-00533
• Device Sequence Number: 15283796
• Product Code: EQJ
• UDI-Device Identifier: 00763000543846
• UDI-Public: 00763000543846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/24/2025

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: 1884004
• Device Catalogue Number: 1884004
• Device Lot Number: 0227106780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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 Sex: Unknown