MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING; BUR, EAR, NOSE AND THROAT

Model Number	1884080EM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the blade 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 and proceeded to the second.The outer assembly was deformed.There was no evidence of concentricity issues or bends in the returned tube / shaft assemblies.There was uneven wear at the cutting tips.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) via a manufacturer representative reported that during a transphenoidal surgery, the inner cutting cannula fractured off.This happened with two different blades using the same handpiece.After the second blade fractured, the handpiece was switched as the hcp thought the handpiece was causing the issue; however, a third blade fractured.All parts three pieces of the blades were removed from the patient using a pickup instrument with no issue.The power console was set at 5k and on oscillating movement.The procedure was delayed approximately 25 minutes due to switching the blades and handpiece.The case was completed using a different blade.No further actions was taken.There was no patient impact.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7909889
• Report Number: 1045254-2018-00467
• Device Sequence Number: 1347079
• Product Code: EQJ
• UDI-Device Identifier: 00613994617422
• UDI-Public: 00613994617422
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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 Expiration Date: 06/30/2020
• Device Model Number: 1884080EM
• Device Catalogue Number: 1884080EM
• Device Lot Number: 0215825281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 127