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	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that visually, the distal tip had broken off the inner cutter.The portion that became detached measured approximately 0.24¿ in length.The break occurred at the first proximal tooth valley.Note that the distal tip outside diameter of the inner cutter (expanded area) could not be determined if it was a turned / machined finish when compared the remainder of the tube.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.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported that the engagement of the device to the bone failed and that the tip of the inner tube was broken during polypectomy on an endoscopic sinus surgery procedure.The device was used for the first time.There was no delay.The procedure was completed with a backup device.There was no patient impact.

• 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: 8583983
• Report Number: 1045254-2019-00227
• Device Sequence Number: 2016662
• 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
• Report Date (Section B): 05/06/2019

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: HG304MP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1