MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 2.9MM 11CM LONG; BUR, EAR, NOSE AND THROAT

Model Number	1882904
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product analysis; discarded by user.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The shaver tricut blade 2.9mm was used for an endoscopic turbinoplasty.During the procedure the inner blade broke off while in use.There were no evident particles in the patient.The team acted quickly and contacted the radiographer to come to theatre (operating room).Multiple images were taken from the patient¿s head to chest and at different angles.The incident occurred near the end and a new blade was opened to complete the procedure.The time the patient was in theatre was lengthened.However, the patient is alive and well and was informed of the incident.

• Brand Name: TRICUT® STRAIGHT SHAFT 2.9MM 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: 7603159
• Report Number: 1045254-2018-00247
• Device Sequence Number: 19238445
• Product Code: EQJ
• UDI-Device Identifier: 20681490047269
• UDI-Public: 20681490047269
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 11/20/2025
• Device Model Number: 1882904
• Device Catalogue Number: 1882904
• Device Lot Number: 0214452950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/14/2018
• 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