Reported Reactions

Devices › Bur, ear, nose and throat

Device brand name · Bur ear nose and throat

Microdebrider Blades And Burs: medical device reports filed with FDA

412 reports name it, 2018–2026. Manufacturer given most often on reports: Medtronic Xomed. Product code EQJ.

412
device reports naming the brand
0% of all MAUDE reports · about 50 a year
53
reports, 12 months to August 2026
96 in the 12 months before
98.3%
classified as malfunction
93.4% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 412 reports that name the brand "Microdebrider Blades And Burs" (bur ear nose and throat), received between April 2018 and August 2026; the manufacturer given most often on reports is Medtronic Xomed. Spellings of one product vary from report to report.

53 reports arrived in the 12 months to August 2026, down 45% from 96 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.3%) and injury (1.7%); across all bur, ear, nose and throat reports (product code EQJ) death is recorded in 0.1% and malfunction in 93.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (74%), vibration (19.7%) and physical resistance/sticking (14.3%). The patient problems coded most often are eye injury and intraoperative cardiac valve injury. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

0918Sep 2021: 2Oct 2021: 3Nov 2021: 1Dec 2021: 02022Jan 2022: 0Feb 2022: 5Mar 2022: 7Apr 2022: 10May 2022: 12Jun 2022: 5Jul 2022: 11Aug 2022: 3Sep 2022: 7Oct 2022: 10Nov 2022: 10Dec 2022: 112023Jan 2023: 4Feb 2023: 11Mar 2023: 9Apr 2023: 10May 2023: 4Jun 2023: 9Jul 2023: 7Aug 2023: 6Sep 2023: 5Oct 2023: 10Nov 2023: 5Dec 2023: 32024Jan 2024: 13Feb 2024: 6Mar 2024: 6Apr 2024: 8May 2024: 18Jun 2024: 7Jul 2024: 8Aug 2024: 2Sep 2024: 6Oct 2024: 3Nov 2024: 2Dec 2024: 122025Jan 2025: 18Feb 2025: 8Mar 2025: 11Apr 2025: 14May 2025: 6Jun 2025: 8Jul 2025: 5Aug 2025: 3Sep 2025: 4Oct 2025: 2Nov 2025: 1Dec 2025: 32026Jan 2026: 5Feb 2026: 3Mar 2026: 13Apr 2026: 9May 2026: 4Jun 2026: 5Jul 2026: 2Aug 2026: 2

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

046912018: 320182020: 420202021: 1420212022: 9120222023: 8320232024: 9120242025: 8320252026: 432026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.7%7
Malfunction98.3%405
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%412
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 2,731 reports carrying product code EQJ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke30574%53.7%
Vibration8119.7%21.4%
Physical resistance/sticking5914.3%4.4%
Mechanical jam235.6%3.4%
Connection problema connection problem81.9%1.1%
Material separation81.9%5.9%
Material fragmentation71.7%12%
Mechanical problema mechanical problem30.7%0.7%
Material integrity problema problem with the device material20.5%0.1%
Noise, audible20.5%0.8%
Difficult to removethe device was hard to remove10.2%0%
Failure to disconnect10.2%0%
Fitting problem10.2%0.1%
Fracturea broken bone10.2%0.5%
Material deformation10.2%0.3%
Off-label use10.2%0%
Overheating of device10.2%2.5%
Power problem10.2%0%
Separation failure10.2%0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Eye injury10.2%
Intraoperative cardiac valve injury10.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureMicrodebrider Blades And BursProduct code EQJAll MAUDE reports
Reports4122,73126,136,888
Share of that pool—15.1%0%
Classified as death, per 1,000 reports019
Classified as injury1.7%5.8%36.2%
Classified as malfunction98.3%93.4%62.3%
Filed by the manufacturer100%97.9%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code EQJ

BrandReportsLatest 12 monthsClassified as death
Xps Blade580710%
Xps Bur - Unknown371460%
Xps Bur290120%
Xps System Navigated Blade194110%
Arthrex332280%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Microdebrider Blades And Burs reports

How many FDA reports name Microdebrider Blades And Burs?

412 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 53 in the latest 12 months.

What kinds of events are reported?

malfunction (98.3%) and injury (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (74%), vibration (19.7%), physical resistance/sticking (14.3%), mechanical jam (5.6%) and connection problem (1.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Microdebrider Blades And Burs was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.