MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE; BUR, EAR, NOSE AND THROAT

Model Number 1884004HR

Device Problem Material Separation (1562)

Patient Problems Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

Analysis found that visually, the distal tip had broken off the inner cutter.The portion that became detached was not returned however it would have measured approximately 0.24¿ in length.The break occurred at the first proximal tooth valley.The outer assembly was deformed.There was wear around the circumference of the inner shaft 0.55¿ from the distal face of the inner hub.There was uneven wear at the cutting tip.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional reported via a manufacturer representative that a small piece of blade broke off inside the sheath into the patient during a submucous resection procedure.A new blade was opened and the case was completed.There was delay in the procedure.The missing piece was not located after several xrays.The patient is fine and had no issues after the procedure.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 8055325
• MDR Text Key: 126679787
• Report Number: 1045254-2018-00580
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074079530
• UDI-Public: 00885074079530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: HG2PAX8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 55