Reported Reactions

Devices › Bit, drill

Device brand name · Bit drill

1 1mm Drill Bit/Mqc For Threaded Hole/56mm: medical device reports filed with FDA

164 reports name it, 2016–2026. Manufacturer given most often on reports: Synthes. Product code HTW.

164
device reports naming the brand
0% of all MAUDE reports · about 16 a year
20
reports, 12 months to August 2026
8 in the 12 months before
57.3%
classified as malfunction
85.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 164 reports that name the brand "1 1mm Drill Bit/Mqc For Threaded Hole/56mm" (bit drill), received between May 2016 and July 2026; the manufacturer given most often on reports is Synthes. Spellings of one product vary from report to report.

20 reports arrived in the 12 months to August 2026, up 150% from 8 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 (57.3%) and injury (42.7%); across all bit, drill reports (product code HTW) death is recorded in 0% and malfunction in 85.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (89.6%), entrapment of device (36%) and failure to cut (4.3%). The patient problems coded most often are foreign body in patient, injury and device embedded in tissue or plaque. 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

035Sep 2021: 2Oct 2021: 0Nov 2021: 1Dec 2021: 12022Jan 2022: 1Feb 2022: 0Mar 2022: 1Apr 2022: 1May 2022: 0Jun 2022: 3Jul 2022: 1Aug 2022: 0Sep 2022: 1Oct 2022: 4Nov 2022: 0Dec 2022: 12023Jan 2023: 1Feb 2023: 1Mar 2023: 2Apr 2023: 2May 2023: 1Jun 2023: 0Jul 2023: 5Aug 2023: 2Sep 2023: 3Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 1Feb 2024: 1Mar 2024: 1Apr 2024: 2May 2024: 3Jun 2024: 2Jul 2024: 3Aug 2024: 1Sep 2024: 1Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 3Mar 2025: 1Apr 2025: 0May 2025: 1Jun 2025: 0Jul 2025: 0Aug 2025: 2Sep 2025: 2Oct 2025: 1Nov 2025: 0Dec 2025: 22026Jan 2026: 1Feb 2026: 1Mar 2026: 5Apr 2026: 3May 2026: 2Jun 2026: 2Jul 2026: 1Aug 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

013262016: 520162017: 122018: 1320182019: 122020: 2420202021: 262022: 1320222023: 172024: 1520242025: 122026: 152026

Event type and report source

Event type, as classified on the report

Death0%0
Injury42.7%70
Malfunction57.3%94
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%164
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 17,868 reports carrying product code HTW. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke14789.6%58.1%
Entrapment of device5936%5.9%
Failure to cut74.3%7%
Material fragmentation31.8%2.1%
Material deformation21.2%4.5%
Material twisted/bent21.2%2.7%
Device or device fragments location unknown10.6%0.1%

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
Foreign body in patientpart of a device left in the patient7445.1%
Injurya physical injury63.7%
Device embedded in tissue or plaque31.8%
Not applicable21.2%
No patient involvement10.6%

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

In context

Measure1 1mm Drill Bit/Mqc For Threaded Hole/56mmProduct code HTWAll MAUDE reports
Reports16417,86826,136,888
Share of that pool—0.9%0%
Classified as death, per 1,000 reports009
Classified as injury42.7%13.5%36.2%
Classified as malfunction57.3%85.1%62.3%
Filed by the manufacturer100%94.2%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 HTW

BrandReportsLatest 12 monthsClassified as death
Quickset 1pc Flex Drill Bit 252,2871580%
Quickset 1pc Flex Drill Bit 35991380%
Quickset 1pc Flex Drill Bit 30951490%
2 0mm Drill Bit With Depth Mark/Qc/140mm360190%
6mm/9mm Cannulated Stepped Drill Bit328230%
Quickset5255200%
UNK - Drill Bits: Trauma285140%
4 2mm Three-Fluted Drill Bit Qc/Needle Point/145mm228440%
Quickset 1pc Flex Drill Bit 45263110%
45 Deg Angle Drill212110%
3 2mm Three-Fluted Drill Bit Qc/Needle Point/145mm198230%
1 8mm Drill Bit With Depth Mark/Qc/110mm186100%
3 8mm Drill Bit 25mm184140%
2 8mm Drill Bit/Qc/165mm16680%
Pin Rev Dome Drill 25mm172110%

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 1 1mm Drill Bit/Mqc For Threaded Hole/56mm reports

How many FDA reports name 1 1mm Drill Bit/Mqc For Threaded Hole/56mm?

164 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 20 in the latest 12 months.

What kinds of events are reported?

malfunction (57.3%) and injury (42.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (89.6%), entrapment of device (36%), failure to cut (4.3%), material fragmentation (1.8%) and material deformation (1.2%). 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 1 1mm Drill Bit/Mqc For Threaded Hole/56mm 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.