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

Model Number	1884004HR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product analysis available; the device has not been returned for inspection.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure the tip of a tricut blade broke off in the patient; the surgeon was able to retrieve the fragment after 20 minutes.A new blade was opened and used to complete the procedure without any patient injury.
Additional Manufacturer Narrative
The completed analysis indicated that one opened sample of part number 1884004hr, from lot number 0214863707 was received.This lot was manufactured february 6, 2018 the reported failure was that the inner tip broke off, and visually, the distal tip had broken off the inner cutter which would have resulted in the reported event.The portion that became detached measured approximately 0.25¿ in length, where the break occurred at the first proximal tooth valley.The outer assembly was deformed in such a way that indicates the inner blade teeth impacted the outer teeth at the 4th proximal tooth while moving in a clockwise direction.There were no signs of misuse or mishandling and no evidence of concentricity issues or bending in the outer tube.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.The customer complaint was confirmed, and there was an out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure the tip of a tricut blade broke off in the patient; the surgeon was able to retrieve the fragment after 20 minutes.A new blade was opened and used to complete the procedure without any patient injury.
Additional Manufacturer Narrative
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 XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7512891
• Report Number: 1045254-2018-00201
• Device Sequence Number: 19238468
• Product Code: EQJ
• UDI-Device Identifier: 20885074079534
• UDI-Public: 20885074079534
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 02/05/2022
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: 0214863707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 06/19/2018; 08/08/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 07/11/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1