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

Model Number 1884080EM

Device Problems Material Separation (1562); Obstruction of Flow (2423)

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

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider (hcp) reported that the tip of the blade broke off in the patient.There was no patient impact reported.

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.The assemblies were deformed in such a way that indicates the inner blade teeth impacted the outer cutting edge at the 1st proximal tooth while moving in a ccw direction which resulted in the observed break.There was no evidence of concentricity issues or bends in the returned tube / shaft assemblies.There was minor wear on the shaft 0.56¿ from the distal face of the inner hub.There was uneven wear at the cutting tip as well.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information received from the health care provider (hcp) reported that there were two different shavers; one in the middle of a case clogged a couple of times and then the tip of the inner blade shaft broke off and fell into the patient.There was no patient impact or injury.

• Brand Name: TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7945151
• MDR Text Key: 123067738
• Report Number: 1045254-2018-00480
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00613994617422
• UDI-Public: 00613994617422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2020
• Device Model Number: 1884080EM
• Device Catalogue Number: 1884080EM
• Device Lot Number: 0215860494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1