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

Model Number 1884004

Device Problem Vibration (1674)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Event Description

It was reported that pre-op, the blade was wobbling while running.User noticed the inner blade was wobbling.There was a procedural delay of fifteen minutes.The procedure was completed with backup products.There was no patient impact.

Manufacturer Narrative

H3: product analysis found visually, when returned, a yellow bag contained tyvek, stylet, 1 clip, 2 clamps, and the blade.The inner shaft was bent when returned.The shaft was bent near the distal end of the inner hub.There were no traces of contamination found on the blade.However, there were traces of indentions found at the proximal end of the outer hub.There were also traces of excess adhesive found at the proximal end of the outer hub (outside diameter of the hub).The outside diameter of the locking area shall be 0.340 +0.003/-0.001 inches and the high spots of adhesive measured up to 0.352 inches which was out of specification.Functionally, despite being bent, the inner assembly still rotated freely by a hand.The device could not be secured into the handpiece and further functional testing could not be performed.In the returned condition, there was an out of specification condition that was related to the complaint.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
• Type of Device: 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: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 19189321
• MDR Text Key: 341125227
• Report Number: 1045254-2024-00611
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00763000543846
• UDI-Public: 00763000543846
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

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
• Device Operator: Health Professional
• Device Model Number: 1884004
• Device Catalogue Number: 1884004
• Device Lot Number: 0227367303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female