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 Problem Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

A health care provider (hcp) reported via manufacturer representative that a piece of metal from the blade was discovered in a patients ethmoid sinus during the post-op appointment for functional endoscopic sinus surgery.The blade was routine use like he always uses it, nothing special or unique in the use of the blade.The initial surgery occurred last (b)(6) and the remnant was found (b)(6).The physician was able to remove the piece of blade from the sinus.They will be performing additional imaging of the patients head and neck to ensure no additional remnants left in the patient.The patient was doing well.The ct images shows that there were no other fragments and nothing was found in the patient's head, neck and abdomen.There was no patient impact.

Manufacturer Narrative

(b)(4) no longer applies to this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis found that only the tip remnant of the blade was returned.Visual/physical examination was done and found that there pieces were broken.If information is provided in the future, a supplemental report will be issued.

• 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: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 8037033
• MDR Text Key: 126069037
• Report Number: 1045254-2018-00556
• Device Sequence Number: 1
• Product Code: EQJ
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884080EM
• Device Catalogue Number: 1884080EM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 01/04/2019; 04/10/2019
• Supplement Dates FDA Received: 01/31/2019; 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 116