MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE; BUR, EAR, NOSE AND THROAT

Model Number	1884080HR
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
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 device was damaged during a functional endoscopic sinus surgery (fess).The procedure was completed with a back-up device.There was no delay in the procedure.There was no patient impact.
Additional Manufacturer Narrative
The biological contaminants were cleaned off the device for the analysis.However the inner was spun by hand and it would randomly bind.There were no detached or loose components.Visually, there was wear inside the distal tip cutting areas which is likely what caused the binding of the inner cutter which may have been the damage the customer was reporting.Functionally, the blade loaded into the handpiece, ran at 5,000 rpm in oscillate mode, and cut saw bone with no issues.Although there was wear on the components, it did not affect the function of the device.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information from a healthcare professional (hcp) reported that there were no fragments detached.The blade just ceased to function or oscillate.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 13CM 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: 8625813
• Report Number: 3004209178-2019-09947
• Device Sequence Number: 1857909
• Product Code: EQJ
• UDI-Device Identifier: 00613994233325
• UDI-Public: 00613994233325
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/12/2019

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: 08/24/2022
• Device Model Number: 1884080HR
• Device Catalogue Number: 1884080HR
• Device Lot Number: HG2S4PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/16/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1