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FDA product code HBE · class 2 · Neurology
Drills, burrs, trephines & accessories (simple, powered): medical device reports filed with FDA
22,777 reports carry this product code, 1993–2026; 30 brands with a page.
- 22,777
- reports with this product code
- 0.1% of all MAUDE reports
- 6,950
- reports, 12 months to August 2026
- 1,907 in the 12 months before
- 96.7%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code HBE is FDA's classification for "Drills, burrs, trephines & accessories (simple, powered)" (neurology panel), a class 2 device. 22,777 medical device reports carry this product code, 0.1% of the MAUDE database, from April 1993 to August 2026.
6,950 reports arrived in the 12 months to August 2026, up 264% from 1,907 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 (96.7%), injury (3.1%) and other (0.1%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Mdt Powered Surgical Solutions | 8,055 | 35.4% |
| Stryker Instruments-Kalamazoo | 2,891 | 12.7% |
| Stryker Instruments-A Division Of Stryker | 2,641 | 11.6% |
| Stryker Instruments Kalamazoo | 2,073 | 9.1% |
| Depuy Synthes Power Tools | 2,003 | 8.8% |
| Medtronic Xomed | 1,533 | 6.7% |
| Depuy Synthes Products | 959 | 4.2% |
| Stryker Ireland | 430 | 1.9% |
| Medtronic Midas Rex | 329 | 1.4% |
| Biomet Microfixation | 322 | 1.4% |
| The Anspach Effort | 290 | 1.3% |
| Blue Belt Technologies | 179 | 0.8% |
| Medtronic Sofamor Danek USA | 82 | 0.4% |
| Stryker Osteosynthesis Freiburg | 63 | 0.3% |
| Stryker Leibinger Freiburg | 62 | 0.3% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Overheating of device | 6,130 | 26.9% |
| Fracturea broken bone | 2,410 | 10.6% |
| Breakthe device broke | 2,058 | 9% |
| Detachment of device or device componentpart of the device came off | 1,502 | 6.6% |
| Flaked | 1,403 | 6.2% |
| Naturally worn | 1,014 | 4.5% |
| Vibration | 786 | 3.5% |
| Difficult to insertthe device was hard to insert | 718 | 3.2% |
| Self-activation or keying | 517 | 2.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 388 | 1.7% |
| Temperature problem | 372 | 1.6% |
| Noise, audible | 362 | 1.6% |
| Loss of powerthe device lost power | 333 | 1.5% |
| Difficult to removethe device was hard to remove | 329 | 1.4% |
| Bent | 306 | 1.3% |
| Device displays incorrect message | 297 | 1.3% |
| Excessive heating | 276 | 1.2% |
| Fluid/blood leak | 247 | 1.1% |
| Detachment of device component | 227 | 1% |
| Material fragmentation | 226 | 1% |
Questions about drills, burrs, trephines & accessories (simple, powered) reports
What is product code HBE?
FDA's classification code for "Drills, burrs, trephines & accessories (simple, powered)", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
22,777 reports through August 2026, 6,950 of them in the latest 12 months.
Which brands appear most often?
Midas Rex MR8 (6,229), Unknown_InstrumentstIre_Product (870), Micro Sagittal Saw (764), Ipc Handpiece - Indigo Drill (727) and Perforator Driver W/Hudson End (683). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.