MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 3.5MM 11CM LONG; BUR, EAR, NOSE AND THROAT

Model Number	1883504
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported via a manufacturer representative that the tip of the inner blade broke off within 5 minute s of use during a functional endoscopic sinus surgery procedure.There was a 15-20 minute delay in retrieving the fragments of the tip of the blade in the surgical site.The procedure was completed with the use of another blade.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that visually, the distal tip had broken off the inner cutter.The portion that became detached measured approximately 0.16¿ in length.The break occurred at the first proximal tooth valley.The outer assembly was deformed.Comparing the fragment with the remainder of the inner assembly, there was a triangular portion missing which includes a tooth (2nd proximal).The proximal end of the front hub and distal end of the inner hub were deformed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRICUT® STRAIGHT SHAFT 3.5MM 11CM LONG
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7969320
• Report Number: 1045254-2018-00515
• Device Sequence Number: 1681662
• Product Code: EQJ
• UDI-Device Identifier: 00681490047364
• UDI-Public: 00681490047364
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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: 03/20/2026
• Device Model Number: 1883504
• Device Catalogue Number: 1883504
• Device Lot Number: 0215129484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR