Device brand name · Twist drill
Level One: medical device reports filed with FDA
231 reports name it, 2020–2026. Manufacturer given most often on reports: St Paul. Product code HTW.
- 231
- device reports naming the brand
- 0% of all MAUDE reports · about 38 a year
- 31
- reports, 12 months to August 2026
- 26 in the 12 months before
- 45.9%
- classified as malfunction
- 85.1% across the product code
- 1.7%
- classified as death, as reported
- 4 reports · not verified by FDA
231 medical device reports received by FDA name the brand "Level One" (twist drill); the manufacturer given most often on reports is St Paul; received from June 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
31 reports arrived in the 12 months to August 2026, up 19% from 26 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 injury (52.4%), malfunction (45.9%) and death (1.7%); 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 (33.3%), fracture (20.8%) and fluid/blood leak (14.7%). The patient problems coded most often are device embedded in tissue or plaque, no patient involvement and hypovolemic shock. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
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) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 77 | 33.3% | 58.1% |
| Fracturea broken bone | 48 | 20.8% | 7.7% |
| Fluid/blood leak | 34 | 14.7% | 0% |
| Power problem | 15 | 6.5% | 0% |
| Temperature problem | 14 | 6.1% | 0% |
| Device alarm system | 7 | 3% | 0% |
| Display or visual feedback problem | 7 | 3% | 0% |
| Failure to calibrate | 4 | 1.7% | 0% |
| Infusion or flow problema problem with flow or infusion | 4 | 1.7% | 0% |
| Insufficient flow or under infusion | 4 | 1.7% | 0% |
| No audible alarm | 3 | 1.3% | 0% |
| Audible prompt/feedback problem | 2 | 0.9% | 0% |
| Circuit failure | 2 | 0.9% | 0% |
| Improper flow or infusion | 2 | 0.9% | 0% |
| Material fragmentation | 2 | 0.9% | 2.1% |
| Material separation | 2 | 0.9% | 0.1% |
| Application program problem | 1 | 0.4% | 0% |
| Calibration problem | 1 | 0.4% | 0% |
| Crackthe device cracked | 1 | 0.4% | 0.3% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.4% | 0% |
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) | Reports | Share |
|---|---|---|
| Device embedded in tissue or plaque | 118 | 51.1% |
| No patient involvement | 12 | 5.2% |
| Hypovolemic shock | 4 | 1.7% |
| Deaththe patient died; cause not stated by this term | 3 | 1.3% |
| Foreign body in patientpart of a device left in the patient | 3 | 1.3% |
| Impaired healingslow healing | 2 | 0.9% |
| Nonunion/delayed-union bone fracture | 1 | 0.4% |
| Partial thickness (second degree) burn | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Level One | Product code HTW | All MAUDE reports |
|---|---|---|---|
| Reports | 231 | 17,868 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 17 | 0 | 9 |
| Classified as injury | 52.4% | 13.5% | 36.2% |
| Classified as malfunction | 45.9% | 85.1% | 62.3% |
| Filed by the manufacturer | 97.4% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Quickset 1pc Flex Drill Bit 25 | 2,287 | 158 | 0% |
| Quickset 1pc Flex Drill Bit 35 | 991 | 38 | 0% |
| Quickset 1pc Flex Drill Bit 30 | 951 | 49 | 0% |
| 2 0mm Drill Bit With Depth Mark/Qc/140mm | 360 | 19 | 0% |
| 6mm/9mm Cannulated Stepped Drill Bit | 328 | 23 | 0% |
| Quickset | 525 | 520 | 0% |
| UNK - Drill Bits: Trauma | 285 | 14 | 0% |
| 4 2mm Three-Fluted Drill Bit Qc/Needle Point/145mm | 228 | 44 | 0% |
| Quickset 1pc Flex Drill Bit 45 | 263 | 11 | 0% |
| 45 Deg Angle Drill | 212 | 11 | 0% |
| 3 2mm Three-Fluted Drill Bit Qc/Needle Point/145mm | 198 | 23 | 0% |
| 1 8mm Drill Bit With Depth Mark/Qc/110mm | 186 | 10 | 0% |
| 3 8mm Drill Bit 25mm | 184 | 14 | 0% |
| 2 8mm Drill Bit/Qc/165mm | 166 | 8 | 0% |
| 1 1mm Drill Bit/Mqc For Threaded Hole/56mm | 164 | 20 | 0% |
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 Level One reports
How many FDA reports name Level One?
231 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 31 in the latest 12 months.
What kinds of events are reported?
injury (52.4%), malfunction (45.9%) and death (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (33.3%), fracture (20.8%), fluid/blood leak (14.7%), power problem (6.5%) and temperature problem (6.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Level One 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.