Reported Reactions

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

0871732000: 320002001: 17320012002: 162002

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.5%1
Malfunction99%190
Other0%0
Not given0.5%1

Who filed the report

Manufacturer report99.5%191
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.5%1

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)ReportsShareShare across product code
Fluid/blood leak7539.1%6.3%
Heat2814.6%1.1%
Leak/splashthe device leaked2714.1%4.4%
Overheating of device2010.4%15.4%
Vibration2010.4%1.5%
Smoking189.4%0.5%
Noise94.7%0.3%
Repair63.1%0.4%
Loss of powerthe device lost power52.6%1.8%
Replace52.6%1.1%
Abnormal21%0%
Contamination21%0.2%
Detachment of device component21%1.3%
Device emits odor21%0.1%
Device, removal of (non-implant)21%0.1%
Hole in material21%2.5%
Material disintegration21%0.5%
Material separation21%0.8%
Mechanical problema mechanical problem21%0.5%
Other (for use when an appropriate device code cannot be identified)21%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)ReportsShare
Therapy/non-surgical treatment, additional42.1%
Other (for use when an appropriate patient code cannot be identified)31.6%
Surgical procedure, additional21%
Burn(s)a burn10.5%
Chemical exposure10.5%
Contamination, chemical10.5%
Foreign body, removal of10.5%
Hearing loss10.5%
Treatment with medication(s)10.5%

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

In context

MeasureMidas Rex Convertible 8 BarProduct code HBBAll MAUDE reports
Reports1929,84826,136,888
Share of that pool—1.9%0%
Classified as death, per 1,000 reports009
Classified as injury0.5%2.7%36.2%
Classified as malfunction99%96.8%62.3%
Filed by the manufacturer99.5%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

BrandReportsLatest 12 monthsClassified as death
Blackmax-Neuro76900%
Midas Rex6885910%
Midas Rex MR87,2626,4160%
Midas Rex Legend9523560%
Air Pen Drive619220%
Legend Footed Attachment43500%
Blackmax System Motor35800%
Maestro Drill35500%
Maestro Medium Fixed Duraguard38100%
Blackmax-Neuro Low Pressure33000%
Midas Rex Legend Footed Attachment21400%
Att Mr8 Angled15900%
Micromax System Motor15900%
ENT Mr86225380%
Compact Speed Reducer 60 132500%

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.