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

Model Number	1884004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via a manufacturer representative that the blade was broken when the lacrimal sac window was opened to remove the uncinate process during the dacryocystorhinostomy (dcr) procedure.There was a risk of foreign matter remaining on the patient.There were no additional actions taken to prevent injury with the blade.There was no delay to the procedure as a back-up blade was used.There was no patient impact.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 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: 8354488
• Report Number: 1045254-2019-00100
• Device Sequence Number: 2126685
• Product Code: EQJ
• UDI-Device Identifier: 20681490047450
• UDI-Public: 20681490047450
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/20/2019

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: 02/06/2026
• Device Model Number: 1884004
• Device Catalogue Number: 1884004
• Device Lot Number: 0214880740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR