Reported Reactions

Devices › Drill, surgical, ent (electric or pneumatic) including handpiece

Device brand name · Drill surgical ent electric or pneumatic including handpiece

Remb Electric Micro Drill: medical device reports filed with FDA

660 reports name it, 2016–2025. Manufacturer given most often on reports: Stryker Instruments-Kalamazoo. Product code ERL.

660
device reports naming the brand
0% of all MAUDE reports · about 67 a year
9
reports, 12 months to August 2026
20 in the 12 months before
99.7%
classified as malfunction
98.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

660 medical device reports received by FDA name the brand "Remb Electric Micro Drill" (drill surgical ent electric or pneumatic including handpiece); the manufacturer given most often on reports is Stryker Instruments-Kalamazoo; received from August 2016 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

9 reports arrived in the 12 months to August 2026, down 55% from 20 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 (99.7%) and injury (0.3%); across all drill, surgical, ent (electric or pneumatic) including handpiece reports (product code ERL) death is recorded in 0% and malfunction in 98.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are overheating of device (61.2%), device remains activated (17%) and detachment of device or device component (11.4%). The patient problems coded most often are no patient involvement, burn(s) and superficial (first degree) burn. 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

0714Sep 2021: 9Oct 2021: 5Nov 2021: 5Dec 2021: 42022Jan 2022: 8Feb 2022: 5Mar 2022: 7Apr 2022: 14May 2022: 4Jun 2022: 10Jul 2022: 10Aug 2022: 4Sep 2022: 10Oct 2022: 8Nov 2022: 3Dec 2022: 52023Jan 2023: 4Feb 2023: 6Mar 2023: 3Apr 2023: 3May 2023: 11Jun 2023: 2Jul 2023: 9Aug 2023: 9Sep 2023: 8Oct 2023: 4Nov 2023: 2Dec 2023: 72024Jan 2024: 1Feb 2024: 2Mar 2024: 10Apr 2024: 2May 2024: 5Jun 2024: 10Jul 2024: 3Aug 2024: 7Sep 2024: 4Oct 2024: 3Nov 2024: 2Dec 2024: 02025Jan 2025: 7Feb 2025: 2Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 1Jul 2025: 0Aug 2025: 1Sep 2025: 2Oct 2025: 6Nov 2025: 0Dec 2025: 12026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

0651292016: 1220162017: 1720172018: 6420182019: 12920192020: 9920202021: 11420212022: 8820222023: 6820232024: 4920242025: 202025

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.3%2
Malfunction99.7%658
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%660
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 29,931 reports carrying product code ERL. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Overheating of device40461.2%43.4%
Device remains activated11217%3.7%
Detachment of device or device componentpart of the device came off7511.4%4%
Fluid/blood leak213.2%3%
Unintended power up182.7%2.5%
Device displays incorrect message162.4%4.3%
Component missing81.2%0.2%
Disassembly50.8%0.6%
Leak/splashthe device leaked40.6%2%
Fracturea broken bone30.5%0.7%
Fail-safe did not operate20.3%0.9%
Material disintegration20.3%0.1%
Smoking20.3%0.6%
Breakthe device broke10.2%5.2%
Detachment of device component10.2%0.5%
Device operates differently than expectedthe device behaved unexpectedly10.2%3%
Material fragmentation10.2%0.6%
Unintended ejection10.2%0%
Unintended movement10.2%0.6%

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
No patient involvement21632.7%
Burn(s)a burn284.2%
Superficial (first degree) burn50.8%
Partial thickness (second degree) burn30.5%

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

In context

MeasureRemb Electric Micro DrillProduct code ERLAll MAUDE reports
Reports66029,93126,136,888
Share of that pool—2.2%0%
Classified as death, per 1,000 reports009
Classified as injury0.3%0.9%36.2%
Classified as malfunction99.7%98.9%62.3%
Filed by the manufacturer100%99.5%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 ERL

BrandReportsLatest 12 monthsClassified as death
Xmax Motor4,44700%
Remb Electric Sagittal Saw1,69340%
Core Impaction Drill3,91300%
S2 Drill844790%
Motor Assembly Xmax893140%
Ipc Handpiece - Xps Straightshot M57111240%
Xps Handpiece - Visao649120%
Ipc Handpiece - Xps Straightshot M4607450%
Pi Drive Plus Motor56400%
Micro Sagittal Saw1,39500%
Core Universal Driver67900%
ENT Mr86225380%
Pi Drive Motor47700%
Core Sumex Drill52200%
Straight Irrigating Attachment454340%

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 Remb Electric Micro Drill reports

How many FDA reports name Remb Electric Micro Drill?

660 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.

What kinds of events are reported?

malfunction (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

overheating of device (61.2%), device remains activated (17%), detachment of device or device component (11.4%), fluid/blood leak (3.2%) and unintended power up (2.7%). 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 Remb Electric Micro Drill 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.