MAUDE Adverse Event Report: MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE; BUR, EAR, NOSE AND THROAT

Model Number	1884004HR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
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 manufacturer representative that during the endoscopic sinus surgery procedure, the blade head was rusting out and throwing metal shards into the patient¿s nose while in use.The tip of the sinus bur began to erode through after a few minutes of using it in the nose (@ 5,000 rpm).The outer cannula was corroded and causing metal shards to come off of it.The metal shards from the tip of the sinus bur where seen in the surgical field and the sinus bur was quickly removed from the patient's nose.There were no corrosive liquids near the sinus bur previous to use.Another tricut blade was opened to complete the procedure.There was no patient impact.
Event or Problem Description
Additional information received mentioned that there was fragments of metal in the patient¿s nose and the surgeon flushed the nose vigorously with sterile normal saline and did a visual inspection to ensure all the metal bits were cleared out of our patient.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3: analysis reported indicated visually the distal tip of the blade was corroded.The inner cutter would spin; however, there was resistance.The inner assembly was removed, and visually, the proximal end of the expanded tip diameter was rough and worn; there was corresponding adjacent damage to the inside diameter of the outer tube.The gouging is consistent with occurring during rotation.The inside diameter of the outer tube shall be 0.135¿/+-0.001¿ a 0.1355¿ pin would not enter into the inside diameter; a 0.1345¿ pin would enter up to where the corresponding damage to the inner cutter occurred (which is in specification).The outside diameter of the inner cutter expanded tip shall be 0.1330¿ / +0.000 / - 0.0010,¿ using a ring gauge.It passed through, meaning it is in the specification.There were no loose components.There was no damage or anomalies in the configuration of the cutting teeth.Functionally the device loaded securely into a handpiece ran at 5,000 rpm in oscillate mode/direction and cut saw bone with no issues or any visual particulates coming from the tip.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 4MM 11CM LONG M4 ROTATABLE
• Common Device Name: 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: 12106636
• Report Number: 1045254-2021-00336
• Device Sequence Number: 4051847
• Product Code: EQJ
• UDI-Device Identifier: 00885074079530
• UDI-Public: 00885074079530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2025
• Device Model Number: 1884004HR
• Device Catalogue Number: 1884004HR
• Device Lot Number: 0221872853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 01/26/2022
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 11/07/2021; 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown