Device brand name · Motor drill pneumatic - handpiece

Blackmax-Neuro: medical device reports filed with FDA

769 reports name it, 2001–2020. Manufacturer given most often on reports: Depuy Synthes Power Tools. Product code HBB.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

769
device reports naming the brand: 0% of all MAUDE reports · about 30 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 98.8%
classified as malfunction: 96.8% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

769 medical device reports received by FDA name the brand "Blackmax-Neuro" (motor drill pneumatic - handpiece); the manufacturer given most often on reports is Depuy Synthes Power Tools; received from March 2001 to February 2020. 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 (98.8%), injury (0.7%) and other (0.4%); 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 break (20.2%), hole in material (11.2%) and device operates differently than expected (10.9%). The patient problems coded most often are no patient involvement, burn(s) and hearing impairment. 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 Blackmax-Neuro was received in the five years to August 2026; the latest was received in February 2020.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0.7%5

Malfunction98.8%760

Other0.4%3

Not given0.1%1

Who filed the report

Manufacturer report100%769

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

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
Breakthe device broke	155	20.2%	4.5%
Hole in material	86	11.2%	2.5%
Device operates differently than expectedthe device behaved unexpectedly	84	10.9%	2.3%
Air leak	78	10.1%	1.2%
Device inoperablethe device could not be used	70	9.1%	1.2%
Leak/splashthe device leaked	55	7.2%	4.4%
Output below specifications	47	6.1%	4.6%
Overheating of device	42	5.5%	15.4%
Noise, audible	38	4.9%	2.4%
Fluid/blood leak	23	3%	6.3%
Cut in material	14	1.8%	0.6%
Mechanical problema mechanical problem	13	1.7%	0.5%
Power problem	13	1.7%	0.4%
Sticking	11	1.4%	2.7%
Temperature problem	9	1.2%	0.8%
Device slipped	7	0.9%	0.1%
Device stops intermittentlythe device stopped now and then	7	0.9%	0.2%
Loose or intermittent connection	7	0.9%	0.1%
Detachment of device or device componentpart of the device came off	6	0.8%	9.5%
Failure to power up	6	0.8%	0.2%

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
No patient involvement	104	13.5%
Burn(s)a burn	1	0.1%
Hearing impairment	1	0.1%

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

In context

Measure	Blackmax-Neuro	Product code HBB	All MAUDE reports
Reports	769	9,848	26,136,888
Share of that pool	—	7.8%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	0.7%	2.7%	36.2%
Classified as malfunction	98.8%	96.8%	62.3%
Filed by the manufacturer	100%	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
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%
Midas Rex Convertible 8 Bar	192	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 Blackmax-Neuro reports

How many FDA reports name Blackmax-Neuro?

769 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 (98.8%), injury (0.7%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (20.2%), hole in material (11.2%), device operates differently than expected (10.9%), air leak (10.1%) and device inoperable (9.1%). 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 Blackmax-Neuro 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.