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

Model Number 3155637

Device Problem Vibration (1674)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by a health care professional that all of the drills and burs used by the doctor during the stapedectomy, the device wobbled instead of rotating in a stable fashion.Instead of the bur creating a small opening in the incus, a fracture was created instead.This happened last week with a different patient.However, this time,the doctor was not certain that all of the fragment out in its entirety.Upon follow up it was confirmed that no bur fragment was suspected to be left behind, as the bur did not break.

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.

Event Description

On follow-up it was reported that the bur was seated correctly.It was verified by the sales representative several times, and the surgeon has been using this type of drill for over 15 years.There was no permanent damage to the patient and not aware of any non-routine actions.

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.

Event Description

There was no permanent damage to the patient.Each of the reported burs that wobbled were initial use, not reprocessed, and some wobbled right out of the package.To troubleshoot the issue, the doctor tried using the burs in different handpieces, to see the result.Each of the burs wobbled in a second handpiece; however, it was found that there was variability on how much of a wobble was evident with each handpiece (either more wobble, or less).The facility determined that this was an issue with their handpiece the injury reported had been resolved; however, it required additional procedures/intervention to address.

Manufacturer Narrative

H3 the product analysis result indicates that there was no damage to the opened bur, which would have resulted in the reported malfunction.The product instruction states, ¿bur assembly shall lock into skeeter handpiece at 700 rpm using oto-tool console indicator without noticeable wobble, visually 100%¿.The returned sample was placed into the handpiece and ran at 1000 rpm [the console minimum rpm is 1000]; there was no ¿noticeable¿ wobble with an unaided eye.When viewed under magnification, there was no visible damage to the green teflon bushing/sleeve.The bur run at 16,000 rpm and cut saw bone with no issues.There is no geometric dimensioning and tolerancing on the applicable drawings that control the reported wobble [i.E., runout, concentricity, true-position].A review of the global complaint data showed only this facility reporting multiple lots with the same failure mechanism.There was no evidence of improper manufacturing and no fault related to the complaint; therefore, manufacturing ruled out as a potential cause.In the returned condition, there was no out-of-condition condition that is likely related to the complaint.H6: additional information suggest that fdm 4114 and fdr 3221 are no longer applicable to this event.There were 2 devices used in the surgery and we're submitting 2 mdrs for the same event list of products involved: drill 3055601fce skeeter oto-tool--fce sn#6490 lot#57060300 regulatory report #: 1045254-2020-00535 bur 3155637 oto-flex.7mm carbide green lot# 0220138822 regulatory report #: 1045254-2020-00536 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: 10790098
• MDR Text Key: 214748447
• Report Number: 1045254-2020-00536
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00681490070492
• UDI-Public: 00681490070492
• 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,Followup,Followup
• Report Date: 05/05/2021

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: 3155637
• Device Catalogue Number: 3155637
• Device Lot Number: 0220138822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/12/2020; 11/19/2020; 04/27/2021
• Supplement Dates FDA Received: 11/30/2020; 12/09/2020; 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other