Reported Reactions

Devices › Broach

Device brand name · Hip instruments handles

Corail2 Anterior Broach Handle: medical device reports filed with FDA

312 reports name it, 2014–2025. Manufacturer given most often on reports: Depuy France Sas - 3003895575. Product code HTQ.

312
device reports naming the brand
0% of all MAUDE reports · about 25 a year
0
reports, 12 months to August 2026
29 in the 12 months before
99.4%
classified as malfunction
94.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 312 reports that name the brand "Corail2 Anterior Broach Handle" (hip instruments handles), received between April 2014 and July 2025; the manufacturer given most often on reports is Depuy France Sas - 3003895575. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 29 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 (99.4%) and injury (0.6%); across all broach reports (product code HTQ) death is recorded in 0% and malfunction in 94.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device-device incompatibility (38.1%), unintended movement (17.3%) and break (14.4%). The patient problems coded most often are not applicable. 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: 3Nov 2021: 0Dec 2021: 22022Jan 2022: 5Feb 2022: 4Mar 2022: 5Apr 2022: 2May 2022: 4Jun 2022: 5Jul 2022: 3Aug 2022: 1Sep 2022: 0Oct 2022: 5Nov 2022: 5Dec 2022: 52023Jan 2023: 3Feb 2023: 1Mar 2023: 1Apr 2023: 0May 2023: 0Jun 2023: 2Jul 2023: 1Aug 2023: 1Sep 2023: 4Oct 2023: 3Nov 2023: 1Dec 2023: 22024Jan 2024: 0Feb 2024: 0Mar 2024: 3Apr 2024: 5May 2024: 1Jun 2024: 2Jul 2024: 1Aug 2024: 2Sep 2024: 3Oct 2024: 4Nov 2024: 2Dec 2024: 42025Jan 2025: 0Feb 2025: 0Mar 2025: 1Apr 2025: 1May 2025: 1Jun 2025: 9Jul 2025: 4Aug 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

022442014: 1320142015: 212016: 2820162017: 122018: 3220182019: 352020: 3620202021: 292022: 4420222023: 192024: 2720242025: 16

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.6%2
Malfunction99.4%310
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%312
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 4,703 reports carrying product code HTQ. 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-device incompatibility11938.1%34.9%
Unintended movement5417.3%7.8%
Breakthe device broke4514.4%25.7%
Structural problem3912.5%2%
Naturally worn144.5%4.9%
Loose or intermittent connection134.2%2.8%
Connection problema connection problem61.9%1.8%
Difficult to open or close61.9%0.4%
Material twisted/bent41.3%2.2%
Scratched material41.3%5.1%
Device slipped31%0.8%
Insufficient device problem information31%0.5%
Material deformation31%5.7%
Entrapment of device20.6%0.6%
Bent10.3%0.5%
Incomplete or inadequate connection10.3%0.1%
Loss of or failure to bond10.3%0%
Material integrity problema problem with the device material10.3%0.9%
Mechanical problema mechanical problem10.3%0.3%

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
Not applicable20.6%

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

In context

MeasureCorail2 Anterior Broach HandleProduct code HTQAll MAUDE reports
Reports3124,70326,136,888
Share of that pool—6.6%0%
Classified as death, per 1,000 reports009
Classified as injury0.6%5.1%36.2%
Classified as malfunction99.4%94.7%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 HTQ

BrandReportsLatest 12 monthsClassified as death
Extra Curved Broach Handle38200%
Summit Universal Broach Handle34100%
Corail Broach Handle26310%
Actis Broach Sz 5235150%
Corail2 Straight Broach Handle20400%
Actis Broach Sz 6191270%
Actis Broach Sz 416780%
Actis Broach Sz 7156120%
Actis2172140%
Dlt Ts Cer Hd 12/14 32mm +115720%
UNK Handle227500%
Quickset Ace Grater Head 56mm898120%
Quickset Ace Grater Head 49mm1,213130%
Quickset Ace Grater Head 50mm954100%
Quickset Ace Grater Head 51mm1,245110%

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 Corail2 Anterior Broach Handle reports

How many FDA reports name Corail2 Anterior Broach Handle?

312 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 (99.4%) and injury (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device-device incompatibility (38.1%), unintended movement (17.3%), break (14.4%), structural problem (12.5%) and naturally worn (4.5%). 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 Corail2 Anterior Broach Handle 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.