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	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.  a follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that the tip of the blade and the jagged part of the inner tube were broken during the endoscopic sinus surgery.The procedure was finished using a back up product.There was no patient impact.
Additional Manufacturer Narrative
Product analysis result indicates that the distal tip had broken off the inner cutter which would have resulted in the reported event.The portion that became detached measured approximately 0.23¿ in length.The break occurred at the first proximal tooth valley.Note ¿the distal tip outside diameter of the inner cutter (expanded area) did not appear to have a turned / machined finish.The assemblies were deformed in such a way that indicates the inner blade teeth impacted the outer cutting edge at the 4th proximal valley while moving in a ccw direction which resulted in the break.There were no signs of bends, concentricity, misuse, or mishandling.There was only minor were at the cutting tip which likely indicates the failure occurred after little use.The inner cutter and outer tube are supplier manufactured; additional components are installed for the final assembled by medtronic.Deformation of the outer tube distal tip has been proven to cause the inner blade tip to fracture / breakage at the first proximal tooth valley.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: 9151478
• Report Number: 1045254-2019-00492
• Device Sequence Number: 19288813
• Product Code: EQJ
• UDI-Device Identifier: 00885074079530
• UDI-Public: 00885074079530
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: 0217586463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1