MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR; BUR, EAR, NOSE AND THROAT

Model Number 31181098E

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Oversedation (1990); Radiation Exposure, Unintended (3164)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A healthcare provider (hcp) reported that back in (b)(6) 2019 they had a product failure when the tip of a bur curved fine diamond bur broke off intra-operatively.This resulted in the patient needing an on table x-ray and extended time under anesthetic.The bur tip was found and the operation was completed.

Manufacturer Narrative

H3: analysis found visually the distal inner shaft broke near the tip which would have resulted in the reported event.The portion that became detached measured 0.111¿ from tip to break.The break corresponds to the distal end of the outer assembly.The fracture configuration showed a smooth outer ring with a rough interior texture which is consistent with being worn through until the breakage occurred.In the location of the break, the nominal shaft diameter on the drawing is 0.0200¿.The remainder of the inner assembly (shaft and tang) were removed from the outer assembly when received and measured 3.776¿ long.The inner shaft was bent just distal to the tang which likely occurred while removing it from the rest of the assembly and there is no evidence to suggest it contributed to this event.There were multiple points along the shaft proximal to the break that were irregularly worn.Both sides of the shaf t break showed discoloration consistent with being heat / friction induced.Providing the product instructions were followed with regard to the cooling the bur, a capillary action / wicking would have caused biological contaminants to become soaked into the cooling sleeve.There were no signs of biological contaminants in the sleeve.The most likely underlying cause is consistent with, misuse / use error.H6: the fdm 4114, fdr 3221 and fdc 67 are no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by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: XPS® BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9780472
• MDR Text Key: 182001660
• Report Number: 1045254-2020-00132
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074322216
• UDI-Public: 00885074322216
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: 31181098E
• Device Catalogue Number: 31181098E
• Device Lot Number: 0216788938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention