MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 3.5MM 11CM LONG M4 ROTATABLE; BUR, EAR, NOSE AND THROAT

Model Number 1883504HR

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

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 via a manufacturer representative that after correct setup of the blade, the polypectomy procedure started.Upon activation of the blade, the most distal portion (tip) has detached within the patient's nose suddenly emerging from the nasal fossa (nasal passage).It was noted that there was no broken pieces/fragments of the reported product that remained inside the patient's body.There was no intervention planned or performed as a result of this event.There was a 10-minute delay in the procedure as a result of this event.The procedure was completed using a back-up device.There was no patient injury.

Manufacturer Narrative

H3: product analysis : analysis of product 1883504hr of lot # 0222900252 found that visually, the distal tip was broken off from the inner shaft and was not returned which would have resulted in the reported event.Under magnification, there were dimples on the outside diameter of the rotating hub.There was no evidence of concentricity issues or bend in the outer tube.Functionally, the inner and middle assemblies spun freely by hand with no binding.Console functional testing was not performed due to the broken portion of the device.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint due to physical damage.H6 : codes updated and previous fdm b17, fdr c20 and fdc d14 codes no loner applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRICUT® STRAIGHT SHAFT 3.5MM 11CM LONG M4 ROTATABLE
• 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: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 13282349
• MDR Text Key: 284982908
• Report Number: 1045254-2022-00028
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00763000518318
• UDI-Public: 00763000518318
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2022

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
• Device Operator: Health Professional
• Device Model Number: 1883504HR
• Device Catalogue Number: 1883504HR
• Device Lot Number: 0222900252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 04/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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 Age: 20 YR
• Patient Sex: Male