Reported Reactions

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

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

Remb Electric Sagittal Saw: medical device reports filed with FDA

1,693 reports name it, 2016–2026. Manufacturer given most often on reports: Stryker Instruments-Kalamazoo. Product code ERL.

1,693
device reports naming the brand
0% of all MAUDE reports · about 171 a year
4
reports, 12 months to August 2026
32 in the 12 months before
99.8%
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 1,693 reports that name the brand "Remb Electric Sagittal Saw" (drill surgical ent electric or pneumatic including handpiece), received between August 2016 and March 2026; the manufacturer given most often on reports is Stryker Instruments-Kalamazoo. Spellings of one product vary from report to report.

4 reports arrived in the 12 months to August 2026, down 87% from 32 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 (99.8%) and injury (0.2%); 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 (70.5%), device remains activated (16%) and unintended power up (6%). The patient problems coded most often are no patient involvement, burn(s) and full thickness (third 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

01632Sep 2021: 25Oct 2021: 18Nov 2021: 22Dec 2021: 182022Jan 2022: 12Feb 2022: 13Mar 2022: 14Apr 2022: 32May 2022: 13Jun 2022: 11Jul 2022: 19Aug 2022: 20Sep 2022: 13Oct 2022: 14Nov 2022: 10Dec 2022: 142023Jan 2023: 9Feb 2023: 7Mar 2023: 15Apr 2023: 22May 2023: 19Jun 2023: 11Jul 2023: 5Aug 2023: 26Sep 2023: 17Oct 2023: 13Nov 2023: 11Dec 2023: 172024Jan 2024: 5Feb 2024: 21Mar 2024: 6Apr 2024: 5May 2024: 8Jun 2024: 5Jul 2024: 14Aug 2024: 6Sep 2024: 12Oct 2024: 9Nov 2024: 4Dec 2024: 32025Jan 2025: 0Feb 2025: 1Mar 2025: 0Apr 2025: 0May 2025: 3Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 1Nov 2025: 0Dec 2025: 02026Jan 2026: 1Feb 2026: 1Mar 2026: 1Apr 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

02044072016: 1420162017: 282018: 8120182019: 3932020: 40720202021: 3072022: 18520222023: 1722024: 9820242025: 52026: 32026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.2%3
Malfunction99.8%1,690
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,693
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 device1,19470.5%43.4%
Device remains activated27116%3.7%
Unintended power up1016%2.5%
Fluid/blood leak382.2%3%
Fracturea broken bone211.2%0.7%
Detachment of device or device componentpart of the device came off181.1%4%
Device displays incorrect message140.8%4.3%
Fail-safe did not operate130.8%0.9%
Fail-safe problem120.7%1.1%
Breakthe device broke110.6%5.2%
Leak/splashthe device leaked80.5%2%
Smoking70.4%0.6%
Disassembly50.3%0.6%
Material disintegration30.2%0.1%
Material fragmentation20.1%0.6%
Component missing10.1%0.2%
Failure to power up10.1%0.1%
Mechanical jam10.1%0.8%
Metal shedding debris10.1%0.2%
Physical resistance/sticking10.1%0.2%

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 involvement69040.8%
Burn(s)a burn30.2%
Full thickness (third degree) burn10.1%

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

In context

MeasureRemb Electric Sagittal SawProduct code ERLAll MAUDE reports
Reports1,69329,93126,136,888
Share of that pool—5.7%0%
Classified as death, per 1,000 reports009
Classified as injury0.2%0.9%36.2%
Classified as malfunction99.8%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%
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%
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 Sagittal Saw reports

How many FDA reports name Remb Electric Sagittal Saw?

1,693 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.

What kinds of events are reported?

malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

overheating of device (70.5%), device remains activated (16%), unintended power up (6%), fluid/blood leak (2.2%) and fracture (1.2%). 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 Sagittal 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.