Reported Reactions

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

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

Remb Electric Reciprocating Saw: medical device reports filed with FDA

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

300
device reports naming the brand
0% of all MAUDE reports · about 30 a year
2
reports, 12 months to August 2026
7 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

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

2 reports arrived in the 12 months to August 2026, down 71% from 7 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 overheating of device (50%), device remains activated (15.3%) and fluid/blood leak (13.3%). 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

059Sep 2021: 2Oct 2021: 2Nov 2021: 3Dec 2021: 42022Jan 2022: 1Feb 2022: 3Mar 2022: 1Apr 2022: 7May 2022: 2Jun 2022: 0Jul 2022: 4Aug 2022: 3Sep 2022: 0Oct 2022: 9Nov 2022: 4Dec 2022: 32023Jan 2023: 1Feb 2023: 5Mar 2023: 3Apr 2023: 3May 2023: 2Jun 2023: 4Jul 2023: 1Aug 2023: 4Sep 2023: 6Oct 2023: 1Nov 2023: 4Dec 2023: 42024Jan 2024: 0Feb 2024: 1Mar 2024: 1Apr 2024: 2May 2024: 3Jun 2024: 2Jul 2024: 1Aug 2024: 0Sep 2024: 3Oct 2024: 1Nov 2024: 0Dec 2024: 12025Jan 2025: 1Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 1Aug 2025: 0Sep 2025: 0Oct 2025: 2Nov 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

031622016: 520162017: 1620172018: 2120182019: 6220192020: 6020202021: 4220212022: 3720222023: 3820232024: 1520242025: 42025

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%300
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%300
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 device15050%43.4%
Device remains activated4615.3%3.7%
Fluid/blood leak4013.3%3%
Unintended power up227.3%2.5%
Detachment of device or device componentpart of the device came off175.7%4%
Leak/splashthe device leaked62%2%
Unintended ejection41.3%0%
Breakthe device broke31%5.2%
Component missing31%0.2%
Device displays incorrect message31%4.3%
Disassembly31%0.6%
Smoking20.7%0.6%
Difficult to insertthe device was hard to insert10.3%0.3%
Fail-safe problem10.3%1.1%
Material disintegration10.3%0.1%
Material fragmentation10.3%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 involvement10836%
Burn(s)a burn20.7%

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

In context

MeasureRemb Electric Reciprocating SawProduct code ERLAll MAUDE reports
Reports30029,93126,136,888
Share of that pool—1%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 Reciprocating Saw reports

How many FDA reports name Remb Electric Reciprocating Saw?

300 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 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?

overheating of device (50%), device remains activated (15.3%), fluid/blood leak (13.3%), unintended power up (7.3%) and detachment of device or device component (5.7%). 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 Reciprocating 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.