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	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No analysis performed; device was not returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
When doctor was using the tricut microdebrider blade during a fess surgery, the blade tip broke off and went missing.They could not find it and had to take the patient to radiology under general anesthesia to perform an x-ray to look for it.One of the staff found it on the floor of the operating room.It was not inside the patient.No patient impact.
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 1884004hr from lot number 0214275685 was received.There was a residue consistent with biological contaminants on the device.A microscope was used to evaluate the device.Visually, the distal tip had broken off the inner cutter which would have resulted in the reported event.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 outer assembly was deformed in such a way that indicates the inner blade teeth impacted the outer teeth at the 3rd proximal valley while moving in a ccw direction which resulted in the observed break.There were no signs of misuse or mishandling.There was no evidence of concentricity issues or bend 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.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
Additional information received from the customer indicates the case was completed with a replacement blade.

• 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: 7333473
• Report Number: 1045254-2018-00106
• Device Sequence Number: 13470531
• Product Code: EQJ
• UDI-Device Identifier: 20885074079534
• UDI-Public: 20885074079534
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/16/2018

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: 10/25/2021
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: 0214275685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR