MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 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	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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 about a tricut blade that fell apart in the middle of a maxillary antrostomy procedure.It was a new blade.The piece was removed from the patient without difficulty.
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 1884004hr, from lot number hg1p84w was received.The distal tip had broken off the inner cutter which would have resulted in the reported event.The portion that became detached measured approximately 0.25¿ 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 2nd proximal valley while moving in a cw direction which resulted in the observed break.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.The teeth and surface profiles are controlled dimensionally and with an overlay tool.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7539859
• Report Number: 3004209178-2018-11720
• Device Sequence Number: 19441796
• Product Code: EQJ
• UDI-Device Identifier: 20885074079534
• UDI-Public: 20885074079534
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 02/22/2021
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: HG1P84W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR