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 Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The blade has not been returned for evaluation.A product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the tip of the blade broke off on approach to the nasal cavity.There was no patient injury and the blade and broken piece of the blade were removed and recovered from the sinus cavity.
Additional Manufacturer Narrative
Product receipt / condition: 1 opened sample, part number 1884004hr, from lot number 0214668745.Results: 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 0.23¿ in length.The break occurred at the first proximal tooth valley.The inner assembly was deformed in such a way that indicates the inner blade teeth impacted the outer teeth at the 2nd distal valley while moving in a cw direction which resulted in the observed break.There was uneven wear at the cutting tip which may indicate an interference fit between the inner and outer assemblies at the tip.¿ complaint substantiated / confirmed: yes ¿ conclusion: 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.

• 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: 7300525
• Report Number: 1045254-2018-00077
• Device Sequence Number: 2116730
• Product Code: EQJ
• UDI-Device Identifier: 20885074079534
• UDI-Public: 20885074079534
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/01/2018

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: 01/03/2022
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: 0214668745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1