Reported Reactions

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

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

Sagitt Saw-Attachm Long W/T-Handle F/Trs: medical device reports filed with FDA

184 reports name it, 2013–2017. Manufacturer given most often on reports: Depuy Synthes Power Tools. Product code HWE.

184
device reports naming the brand
0% of all MAUDE reports · about 14 a year
0
reports, 12 months to August 2026
0 in the 12 months before
100%
classified as malfunction
97.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

184 medical device reports received by FDA name the brand "Sagitt Saw-Attachm Long W/T-Handle F/Trs" (instrument surgical orthopedic ac-powered motor/access and attachment); the manufacturer given most often on reports is Depuy Synthes Power Tools; received from March 2013 to November 2017. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 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 overheating of device (27.7%), device inoperable (21.7%) and device operates differently than expected (14.7%). The patient problems coded most often are no patient involvement. 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

No report naming Sagitt Saw-Attachm Long W/T-Handle F/Trs was received in the five years to August 2026; the latest was received in November 2017.

By year received

033652013: 920132014: 1920142015: 6520152016: 3920162017: 522017

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%184
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%184
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
Overheating of device5127.7%4.2%
Device inoperablethe device could not be used4021.7%6.8%
Device operates differently than expectedthe device behaved unexpectedly2714.7%5.9%
Defective devicethe device was defective168.7%1%
Breakthe device broke116%8.2%
Partial blockage116%2%
Loose or intermittent connection105.4%0.7%
Corrodedthe device corroded94.9%0.4%
Defective component73.8%0.8%
Temperature problem73.8%0.6%
Mechanical jam52.7%13.1%
Detachment of device component42.2%0.9%
Mechanical problema mechanical problem42.2%2.3%
Charging problem31.6%0.1%
Device slipped31.6%0.8%
Difficult to position31.6%0.2%
Positioning problem31.6%0.2%
Device stops intermittentlythe device stopped now and then21.1%0.8%
Difficult to open or close21.1%0.2%
Failure of device to self-test21.1%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 involvement3921.2%

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

In context

MeasureSagitt Saw-Attachm Long W/T-Handle F/TrsProduct code HWEAll MAUDE reports
Reports18450,44026,136,888
Share of that pool—0.4%0%
Classified as death, per 1,000 reports009
Classified as injury0%2.3%36.2%
Classified as malfunction100%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%
Sagittal Saw Attachment Long For Trs1,039900%
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%

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 Sagitt Saw-Attachm Long W/T-Handle F/Trs reports

How many FDA reports name Sagitt Saw-Attachm Long W/T-Handle F/Trs?

184 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?

overheating of device (27.7%), device inoperable (21.7%), device operates differently than expected (14.7%), defective device (8.7%) and break (6%). 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 Sagitt Saw-Attachm Long W/T-Handle F/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.