MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. TRICUT® STRAIGHT SHAFT 4MM 11CM LONG; BUR, EAR, NOSE AND THROAT

Model Number	1884004
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
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 healthcare professional (hcp) reported via a manufacturer representative that the tip of the blade broke off during a functional endoscopic sinus surgery procedure.All the pieces were retrieved.The procedure was delayed for 5 minutes to ensure that all the broken pieces were recovered.A new blade was opened.There was no additional, non-routine action taken to prevent injury.There was no patient impact and that the patient was discharged to home.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 11CM LONG
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8270123
• Report Number: 3004209178-2019-01501
• Device Sequence Number: 1234391
• Product Code: EQJ
• UDI-Device Identifier: 00681490047456
• UDI-Public: 00681490047456
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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 Model Number: 1884004
• Device Catalogue Number: 1884004
• Device Lot Number: HG2WTHB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 66