Reported Reactions

Devices › Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment

Device brand name · Instrument surgical orthopedic ac-powered motor/access and attachment

Sagittal Saw Attachment Long For Trs: medical device reports filed with FDA

1,039 reports name it, 2014–2026. Manufacturer given most often on reports: Synthes. Product code HWE.

1,039
device reports naming the brand
0% of all MAUDE reports · about 85 a year
90
reports, 12 months to August 2026
120 in the 12 months before
99.5%
classified as malfunction
97.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 1,039 reports that name the brand "Sagittal Saw Attachment Long For Trs" (instrument surgical orthopedic ac-powered motor/access and attachment), received between April 2014 and August 2026; the manufacturer given most often on reports is Synthes. Spellings of one product vary from report to report.

90 reports arrived in the 12 months to August 2026, down 25% from 120 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 (99.5%) and injury (0.5%); across all instrument, surgical, orthopedic, ac-powered motor and accessory/attachment reports (product code HWE) death is recorded in 0% and malfunction in 97.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are mechanical jam (67.5%), complete loss of power (44.5%) and excessive heating (19.9%). The patient problems coded most often are burn(s), injury and tissue damage. 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

01937Sep 2021: 8Oct 2021: 12Nov 2021: 8Dec 2021: 202022Jan 2022: 21Feb 2022: 17Mar 2022: 23Apr 2022: 9May 2022: 10Jun 2022: 34Jul 2022: 24Aug 2022: 16Sep 2022: 37Oct 2022: 37Nov 2022: 35Dec 2022: 242023Jan 2023: 17Feb 2023: 19Mar 2023: 20Apr 2023: 18May 2023: 16Jun 2023: 18Jul 2023: 17Aug 2023: 14Sep 2023: 19Oct 2023: 8Nov 2023: 16Dec 2023: 252024Jan 2024: 11Feb 2024: 17Mar 2024: 10Apr 2024: 12May 2024: 16Jun 2024: 22Jul 2024: 22Aug 2024: 9Sep 2024: 9Oct 2024: 13Nov 2024: 3Dec 2024: 72025Jan 2025: 12Feb 2025: 7Mar 2025: 13Apr 2025: 15May 2025: 2Jun 2025: 22Jul 2025: 12Aug 2025: 5Sep 2025: 7Oct 2025: 11Nov 2025: 13Dec 2025: 102026Jan 2026: 5Feb 2026: 8Mar 2026: 6Apr 2026: 8May 2026: 4Jun 2026: 4Jul 2026: 9Aug 2026: 5

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

01442872014: 320142016: 72017: 1720172018: 502019: 2720192020: 462021: 6620212022: 2872023: 20720232024: 1512025: 12920252026: 49

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.5%5
Malfunction99.5%1,034
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,039
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 50,440 reports carrying product code HWE. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Mechanical jam70167.5%13.1%
Complete loss of power46244.5%7.5%
Excessive heating20719.9%3.5%
Overheating of device605.8%4.2%
Corrodedthe device corroded454.3%0.4%
Noise, audible212%6.1%
Device inoperablethe device could not be used171.6%6.8%
Device-device incompatibility151.4%1.3%
Breakthe device broke141.3%8.2%
Detachment of device or device componentpart of the device came off111.1%2.9%
Premature separation101%0.4%
Device operates differently than expectedthe device behaved unexpectedly70.7%5.9%
Material fragmentation40.4%0.9%
Positioning failure40.4%0.1%
Component missing30.3%0.5%
Detachment of device component30.3%0.9%
Vibration30.3%0.9%
Device reprocessing problem20.2%0.1%
Difficult or delayed separation20.2%0.1%
Mechanical problema mechanical problem20.2%2.3%

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
Burn(s)a burn30.3%
Injurya physical injury10.1%
Tissue damage10.1%

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

In context

MeasureSagittal Saw Attachment Long For TrsProduct code HWEAll MAUDE reports
Reports1,03950,44026,136,888
Share of that pool—2.1%0%
Classified as death, per 1,000 reports009
Classified as injury0.5%2.3%36.2%
Classified as malfunction99.5%97.5%62.3%
Filed by the manufacturer100%99.3%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 HWE

BrandReportsLatest 12 monthsClassified as death
Small Battery Drive2,43900%
Colibri1,47200%
Electric Pen Drive 60 000 Rpm1,486940%
Sagittal Saw Attachment1,505640%
Smartlife Large Aspetic Housing1,13220%
Quick Coupling For K-Wires744280%
Epd 60000 Rpm73700%
Air Oscillator65700%
Chuck With Key/Drill Speed For Trs655940%
Small Battery Drive Colibri63300%
Modular Calcar Planer Sml515300%
Sagittal Saw Attachment For Trs428770%
System 6 Sagittal Saw69800%
Unium Modular Handpiece4031370%
Modified Hudson Adapter42500%

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 Sagittal Saw Attachment Long For Trs reports

How many FDA reports name Sagittal Saw Attachment Long For Trs?

1,039 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 90 in the latest 12 months.

What kinds of events are reported?

malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

mechanical jam (67.5%), complete loss of power (44.5%), excessive heating (19.9%), overheating of device (5.8%) and corroded (4.3%). 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 Sagittal Saw Attachment Long For Trs 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.