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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2024
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 (external) noted to the tubing set or the blade.There were traces of contamination observed at the distal end of the outer tube, and at the proximal end of the inner shaft.It was also observed that the gap between the inner and outer hub was uneven.Functionally, the inner assembly spun by hand with binding sound, and the inner and outer blades were not fixed together.The device was loaded into a handpiece and while oscillating up to 7,500rpm, the 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 striations were also observed at the distal end/tip of the shaft and near the distal end of the inner hub.Furthermore, the inner shaft tip was measured, and the outside diameter of the tip shall measure.1330+.000/-.0010 and measured.1328 which was in specification.Despite the alleged complaint, it was observed that the blade could turn, and the inner and outer blades were not fixed together.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 reported that, during intra operative, straight blade was connected to the m5.When the pedal was pressed, the blade did not turn.When the blade was unplugged, the inner and outer blades were fixed together, making it impossible to rotate.There was no patient impact.
Additional Manufacturer Narrative
D4: udi has been updated.H6: annex d/fdc code has been updated.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: 22116253
• Report Number: 1045254-2025-01437
• Device Sequence Number: 12556611
• Product Code: EQJ
• UDI-Device Identifier: 00763000543846
• UDI-Public: (01)00763000543846(17)311010(10)0227539654
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 0227539654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown