MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE; BUR, EAR, NOSE AND THROAT

Model Number	1884004HR
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Device evaluation anticipated but not yet begun.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The facility reported that the tip sprung open during the procedure.There was no patient impact.
Additional Manufacturer Narrative
Product analysis: visually, the tip off the inner cutter was lifted out of the outer cutter mouth opening which would have resulted in the reported event.No portion of the device became detached.A fracture occurred at the first proximal tooth valley.The inner and outer assembly were deformed in such a way that indicates the inner blade teeth impacted the outer teeth at the 2nd proximal valley while moving in a clockwise direction which resulted in the observed fracture.The failure mode in the complaint sample could not be reproduced using non-complaint samples.The areas of the device that are in question are supplied material components.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE
• 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: 6985975
• Report Number: 3004209178-2017-22714
• Device Sequence Number: 488889
• Product Code: EQJ
• UDI-Device Identifier: 20885074079534
• UDI-Public: 20885074079534
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: 05/03/2021
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: HG1TRPX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1