Devices › Motor, drill, pneumatic
Device brand name · Pneumatic surgical drill
Midas Rex Convertible 8 Bar: medical device reports filed with FDA
192 reports name it, 2000–2002. Manufacturer given most often on reports: Medtronic Midas Rex. Product code HBB.
- 192
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99%
- classified as malfunction
- 96.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
192 medical device reports received by FDA name the brand "Midas Rex Convertible 8 Bar" (pneumatic surgical drill); the manufacturer given most often on reports is Medtronic Midas Rex; received from November 2000 to November 2002. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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%) and injury (0.5%); across all motor, drill, pneumatic reports (product code HBB) death is recorded in 0% and malfunction in 96.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (39.1%), heat (14.6%) and leak/splash (14.1%). The patient problems coded most often are therapy/non-surgical treatment, additional, other (for use when an appropriate patient code cannot be identified) and surgical procedure, additional. 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
No report naming Midas Rex Convertible 8 Bar was received in the five years to August 2026; the latest was received in November 2002.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 9,848 reports carrying product code HBB. 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 |
|---|---|---|---|
| Fluid/blood leak | 75 | 39.1% | 6.3% |
| Heat | 28 | 14.6% | 1.1% |
| Leak/splashthe device leaked | 27 | 14.1% | 4.4% |
| Overheating of device | 20 | 10.4% | 15.4% |
| Vibration | 20 | 10.4% | 1.5% |
| Smoking | 18 | 9.4% | 0.5% |
| Noise | 9 | 4.7% | 0.3% |
| Repair | 6 | 3.1% | 0.4% |
| Loss of powerthe device lost power | 5 | 2.6% | 1.8% |
| Replace | 5 | 2.6% | 1.1% |
| Abnormal | 2 | 1% | 0% |
| Contamination | 2 | 1% | 0.2% |
| Detachment of device component | 2 | 1% | 1.3% |
| Device emits odor | 2 | 1% | 0.1% |
| Device, removal of (non-implant) | 2 | 1% | 0.1% |
| Hole in material | 2 | 1% | 2.5% |
| Material disintegration | 2 | 1% | 0.5% |
| Material separation | 2 | 1% | 0.8% |
| Mechanical problema mechanical problem | 2 | 1% | 0.5% |
| Other (for use when an appropriate device code cannot be identified) | 2 | 1% | 1.2% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 4 | 2.1% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 1.6% |
| Surgical procedure, additional | 2 | 1% |
| Burn(s)a burn | 1 | 0.5% |
| Chemical exposure | 1 | 0.5% |
| Contamination, chemical | 1 | 0.5% |
| Foreign body, removal of | 1 | 0.5% |
| Hearing loss | 1 | 0.5% |
| Treatment with medication(s) | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Midas Rex Convertible 8 Bar | Product code HBB | All MAUDE reports |
|---|---|---|---|
| Reports | 192 | 9,848 | 26,136,888 |
| Share of that pool | — | 1.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.5% | 2.7% | 36.2% |
| Classified as malfunction | 99% | 96.8% | 62.3% |
| Filed by the manufacturer | 99.5% | 98.6% | 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 HBB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Blackmax-Neuro | 769 | 0 | 0% |
| Midas Rex | 688 | 591 | 0% |
| Midas Rex MR8 | 7,262 | 6,416 | 0% |
| Midas Rex Legend | 952 | 356 | 0% |
| Air Pen Drive | 619 | 22 | 0% |
| Legend Footed Attachment | 435 | 0 | 0% |
| Blackmax System Motor | 358 | 0 | 0% |
| Maestro Drill | 355 | 0 | 0% |
| Maestro Medium Fixed Duraguard | 381 | 0 | 0% |
| Blackmax-Neuro Low Pressure | 330 | 0 | 0% |
| Midas Rex Legend Footed Attachment | 214 | 0 | 0% |
| Att Mr8 Angled | 159 | 0 | 0% |
| Micromax System Motor | 159 | 0 | 0% |
| ENT Mr8 | 622 | 538 | 0% |
| Compact Speed Reducer 60 1 | 325 | 0 | 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 Midas Rex Convertible 8 Bar reports
How many FDA reports name Midas Rex Convertible 8 Bar?
192 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%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (39.1%), heat (14.6%), leak/splash (14.1%), overheating of device (10.4%) and vibration (10.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Midas Rex Convertible 8 Bar 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.