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

Model Number	1884004
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, at the intra operative, when connecting the blade, the straight blade was that the inner and outer blades were stuck together, which made it impossible to rotate when the blade was connected and the foot pedal was pressed, and it did not affect the surgery.The problem was solved by replacing the blade.The blade was wobbling during analysis.There was no patient impact.
Additional Manufacturer Narrative
H3: visually, 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 and on the envelope.When returned, the styllete was inside the inner assembly, and the gap between inner and outer hub was uneven (one side of the gap was smaller than the other side of the gap).Functionally, the inner assembly spun by hand with binding sound, and the inner and outer assemblies were not stuck together when returned.The device was loaded into a handpiece and while oscillating up to 7 ,500rpm, the device resulted in excessive wobbling.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 was also deep striation observed at the distal end/tip of the shaft.Furthermore, the outside diameter of the tip shall measure.1330+.000/-.0010 and measured.1326 which was in specification.The device failed functional testing due to defective condition upon return and the inability to spin properly.In the returned condition, there was no out of specification condition that was related to the complaint but there were other findings observed during the analysis of the returned device.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: 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: 22033203
• Report Number: 1045254-2025-01348
• Device Sequence Number: 9484596
• 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): 05/16/2025

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: 0227539653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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