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

Model Number	1884004HR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 8055325
• Report Number: 1045254-2018-00580
• Device Sequence Number: 1923459
• Product Code: EQJ
• UDI-Device Identifier: 00885074079530
• UDI-Public: 00885074079530
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 55