MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING; BUR, EAR, NOSE AND THROAT

Model Number	1884080EM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
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 health care provider (hcp) reported via a manufacturer representative that the blade broke into 2 pieces during a septoplasty surgery.The hcp was able to retrieve the broken piece.The hcp noted that this was the initial use of the device.There was no major delay in the procedure and the case was completed using a new blade.There were no non-routine actions taken to prevent impact or injury in association with this device.There was no patient or staff impact.
Additional Manufacturer Narrative
Analysis found that there was a residue consistent with biological contaminants on the device.Visually, the distal tip had broken off the inner cutter which would have resulted in the reported event.Note ¿ the distal tip outside diameter of the inner cutter (expanded area) showed a turned / machined finish when compared the remainder of the tube.The portion that became detached was not returned however it would have measured approximately 0.24¿ in length.The break occurred at the first proximal tooth valley.The assemblies were deformed in such a way that indicates the inner blade teeth impacted the outer cutting edge at the 3rd proximal tooth while moving in a ccw direction which resulted in the observed break.There was no evidence of concentricity issues or bends in the returned tube / shaft assemblies.There was no evidence of misuse or mishandling.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
Additional information was received stating that the procedure was functional endoscopic sinus surgery (fess) with septoplasty and somno.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8090021
• Report Number: 1045254-2018-00623
• Device Sequence Number: 13874183
• Product Code: EQJ
• UDI-Device Identifier: 00613994617422
• UDI-Public: 00613994617422
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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 Expiration Date: 07/29/2020
• Device Model Number: 1884080EM
• Device Catalogue Number: 1884080EM
• Device Lot Number: 0215999061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74