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	01/10/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during the surgery, the blade shook when it was inserted into the handpiece.The procedure was completed with a backup product.There was no patient impact.
Event or Problem Description
Additional information was received indicating that there was no allegation against the handpiece, and when they tried a different blade with the reported handpiece, no issue was observed with the other blade.
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
E: initial reporter details has been updated.H3: product analysis found that visually, the inner shaft was bent distal to the inner hub upon return.There was no damage to the distal tip and no loose components.There was a brownish residue on the outside diameter of the shaft near the tip.Under magnification, there were striations on the proximal end of the outside diameter of the shaft.Functionally, the inner assembly spun freely by hand with no binding.The blade fit securely into a handpiece, but while oscillating up to 7500rpm excessive wobbling was observed.In the returned condition, there was an out of specification condition that was related to the complaint.H6: previously applied fdm b17, fdr c20, fdc d16, imf f2601 and img g04041 codes are no longer applicable.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: 21408592
• Report Number: 1045254-2025-00506
• Device Sequence Number: 9311904
• 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,Followup,Followup
• Report Date (Section B): 04/03/2025

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: 0228584287
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/20/2025; 03/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/17/2025; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2024
• 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 Age: 34 YR
• Patient Sex: Female