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 Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
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 healthcare professional (hcp) reported via a manufacturer representative that the internal blade broke off the outer blade and int o the nasal cavity during an endoscopic resection of nasal tumor angiofibroma.The device started to sound odd.The broken piece was retrieved without damage.There was a 20-minute delay retrieving the broken piece.A backup blade was used and the procedure was completed.There was no patient impact.
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 ¿ the distal tip outside diameter of the inner cutter (expanded area) appeared to be 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 tooth while moving in a cw direction which resulted in the deformation.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 gouging and extensive wear around the outside diameter of the inner shaft 0.55¿ from the distal face of the inner hub indicating metal on metal contact during use.This point corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification, there was deformation and indentations of the front hub locking area consistent with aggressive use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The blade was replaced by another device from the same batch.

• 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: 8503712
• Report Number: 3004209178-2019-07162
• Device Sequence Number: 16479212
• Product Code: EQJ
• UDI-Device Identifier: 20885074079534
• UDI-Public: 20885074079534
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 04/12/2021
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: HG1SR5H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 65