Reported Reactions

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Device brand name · Hip instruments reamers

Quickset Ace Grater Head 51mm: medical device reports filed with FDA

1,245 reports name it, 2015–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code HTO.

1,245
device reports naming the brand
0% of all MAUDE reports · about 111 a year
11
reports, 12 months to August 2026
56 in the 12 months before
99.8%
classified as malfunction
95.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

1,245 medical device reports received by FDA name the brand "Quickset Ace Grater Head 51mm" (hip instruments reamers); the manufacturer given most often on reports is Depuy Orthopaedics US; received from April 2015 to March 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

11 reports arrived in the 12 months to August 2026, down 80% from 56 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 reamer reports (product code HTO) death is recorded in 0% and malfunction in 95.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to cut (68.8%), dull, blunt (17.2%) and naturally worn (11.6%). The patient problems coded most often are not applicable, appropriate clinical signs, symptoms and conditions term/code not available and 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

02855Sep 2021: 13Oct 2021: 33Nov 2021: 40Dec 2021: 192022Jan 2022: 10Feb 2022: 13Mar 2022: 16Apr 2022: 3May 2022: 20Jun 2022: 12Jul 2022: 11Aug 2022: 13Sep 2022: 28Oct 2022: 24Nov 2022: 35Dec 2022: 142023Jan 2023: 22Feb 2023: 24Mar 2023: 16Apr 2023: 11May 2023: 16Jun 2023: 20Jul 2023: 16Aug 2023: 27Sep 2023: 12Oct 2023: 25Nov 2023: 19Dec 2023: 172024Jan 2024: 11Feb 2024: 55Mar 2024: 16Apr 2024: 20May 2024: 34Jun 2024: 18Jul 2024: 14Aug 2024: 13Sep 2024: 24Oct 2024: 1Nov 2024: 9Dec 2024: 02025Jan 2025: 1Feb 2025: 0Mar 2025: 1Apr 2025: 6May 2025: 2Jun 2025: 1Jul 2025: 11Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 8Feb 2026: 1Mar 2026: 2Apr 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

01212412015: 2420152016: 502017: 5120172018: 642019: 6120192020: 822021: 24120212022: 1992023: 22520232024: 2152025: 2220252026: 11

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.2%2
Malfunction99.8%1,243
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,245
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 29,443 reports carrying product code HTO. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to cut85668.8%51.3%
Dull, blunt21417.2%12.7%
Naturally worn14411.6%7.8%
Corrodedthe device corroded675.4%7%
Material twisted/bent332.7%2.4%
Breakthe device broke211.7%13.6%
Material deformation161.3%2%
Illegible information151.2%1%
Crackthe device cracked110.9%0.8%
Device-device incompatibility90.7%3.2%
Contamination /decontamination problem40.3%0.6%
Insufficient device problem information40.3%0.2%
Material discolored30.2%0.5%
Entrapment of device20.2%1.5%
Scratched material20.2%0.3%
Detachment of device or device componentpart of the device came off10.1%0.5%
Device contamination with chemical or other material10.1%0.2%
Failure to clean adequately10.1%0%
Fracturea broken bone10.1%1%

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 applicable80.6%
Appropriate clinical signs, symptoms and conditions term/code not available10.1%
No patient involvement10.1%

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

In context

MeasureQuickset Ace Grater Head 51mmProduct code HTOAll MAUDE reports
Reports1,24529,44326,136,888
Share of that pool—4.2%0%
Classified as death, per 1,000 reports009
Classified as injury0.2%4.1%36.2%
Classified as malfunction99.8%95.7%62.3%
Filed by the manufacturer100%99.2%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 HTO

BrandReportsLatest 12 monthsClassified as death
Quickset Ace Grater Head 49mm1,213130%
Quickset Ace Grater Head 53mm1,197100%
Quickset Ace Grater Head 47mm1,170130%
Quickset Ace Grater Head 55mm1,157100%
Quickset Ace Grater Head 57mm1,09890%
Quickset Ace Grater Head 52mm982100%
Quickset Ace Grater Head 50mm954100%
Quickset Ace Grater Head 48mm95190%
Quickset Ace Grater Head 54mm935100%
Quickset Ace Grater Head 56mm898120%
Quickset Ace Grater Head 45mm1,024130%
Unk Reamer833710%
Quickset Ace Grater Head 46mm83690%
Quickset Ace Grater Head 59mm73990%
Quickset Ace Grater Head 58mm70690%

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 Quickset Ace Grater Head 51mm reports

How many FDA reports name Quickset Ace Grater Head 51mm?

1,245 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 11 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?

failure to cut (68.8%), dull, blunt (17.2%), naturally worn (11.6%), corroded (5.4%) and material twisted/bent (2.7%). 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 Quickset Ace Grater Head 51mm 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.