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

Model Number 1884080HR

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; no analysis has been performed.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that the tips of the tricut blades broke off when they initially started to operate the blades.It happened two times within the same case.The blades were tested prior to using on patient.They switched out the handpiece and the blades, and then they had no further issue.There was no patient impact other than the delay in the surgery getting new blades.This report represents device 2 of 2 for this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMNED, INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMNED, INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7692336
• MDR Text Key: 114549359
• Report Number: 1045254-2018-00296
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884080HR
• Device Catalogue Number: 1884080HR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1