Reported Reactions

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

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

Remb Electric Oscillating Saw: medical device reports filed with FDA

401 reports name it, 2016–2025. Manufacturer given most often on reports: Stryker Instruments-A Division Of Stryker. Product code ERL.

401
device reports naming the brand
0% of all MAUDE reports · about 41 a year
0
reports, 12 months to August 2026
21 in the 12 months before
100%
classified as malfunction
98.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 401 reports that name the brand "Remb Electric Oscillating Saw" (drill surgical ent electric or pneumatic including handpiece), received between September 2016 and July 2025; the manufacturer given most often on reports is Stryker Instruments-A Division Of Stryker. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 21 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 (100%); 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 device remains activated (28.7%), overheating of device (28.7%) and fluid/blood leak (17.2%). The patient problems coded most often are no patient involvement and burn(s). 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

01019Sep 2021: 2Oct 2021: 1Nov 2021: 3Dec 2021: 52022Jan 2022: 0Feb 2022: 2Mar 2022: 4Apr 2022: 5May 2022: 0Jun 2022: 4Jul 2022: 2Aug 2022: 3Sep 2022: 5Oct 2022: 19Nov 2022: 4Dec 2022: 22023Jan 2023: 1Feb 2023: 8Mar 2023: 5Apr 2023: 3May 2023: 2Jun 2023: 6Jul 2023: 7Aug 2023: 4Sep 2023: 1Oct 2023: 1Nov 2023: 2Dec 2023: 22024Jan 2024: 3Feb 2024: 1Mar 2024: 1Apr 2024: 2May 2024: 1Jun 2024: 0Jul 2024: 1Aug 2024: 2Sep 2024: 7Oct 2024: 3Nov 2024: 3Dec 2024: 22025Jan 2025: 1Feb 2025: 0Mar 2025: 0Apr 2025: 1May 2025: 1Jun 2025: 0Jul 2025: 3Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 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

0561112016: 320162017: 1520172018: 2420182019: 8020192020: 4420202021: 11120212022: 5020222023: 4220232024: 2620242025: 62025

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%401
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%401
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
Device remains activated11528.7%3.7%
Overheating of device11528.7%43.4%
Fluid/blood leak6917.2%3%
Detachment of device or device componentpart of the device came off4912.2%4%
Fracturea broken bone153.7%0.7%
Unintended power up92.2%2.5%
Leak/splashthe device leaked82%2%
Disassembly71.7%0.6%
Material fragmentation41%0.6%
Device displays incorrect message30.7%4.3%
Material disintegration30.7%0.1%
Breakthe device broke10.2%5.2%
Corrodedthe device corroded10.2%0%
Fail-safe did not operate10.2%0.9%

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 involvement11227.9%
Burn(s)a burn10.2%

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

In context

MeasureRemb Electric Oscillating SawProduct code ERLAll MAUDE reports
Reports40129,93126,136,888
Share of that pool—1.3%0%
Classified as death, per 1,000 reports009
Classified as injury0%0.9%36.2%
Classified as malfunction100%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%
Remb Electric Micro Drill66090%
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%

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 Oscillating Saw reports

How many FDA reports name Remb Electric Oscillating Saw?

401 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device remains activated (28.7%), overheating of device (28.7%), fluid/blood leak (17.2%), detachment of device or device component (12.2%) and fracture (3.7%). 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 Oscillating Saw 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.