Reported Reactions

Devices › Motor, drill, electric

Device brand name · Motor drill electric - attachment

8cm Angle Attachment: medical device reports filed with FDA

1,476 reports name it, 2012–2026. Manufacturer given most often on reports: Depuy Synthes Power Tools. Product code HBC.

1,476
device reports naming the brand
0% of all MAUDE reports · about 109 a year
6
reports, 12 months to August 2026
18 in the 12 months before
99.7%
classified as malfunction
98.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 1,476 reports that name the brand "8cm Angle Attachment" (motor drill electric - attachment), received between December 2012 and July 2026; the manufacturer given most often on reports is Depuy Synthes Power Tools. Spellings of one product vary from report to report.

6 reports arrived in the 12 months to August 2026, down 67% from 18 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 (99.7%) and injury (0.3%); across all motor, drill, electric reports (product code HBC) death is recorded in 0% and malfunction in 98.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are overheating of device (33.6%), vibration (15.6%) and excessive heating (14.8%). The patient problems coded most often are no patient involvement, burn(s) and injury. 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

047Sep 2021: 4Oct 2021: 1Nov 2021: 6Dec 2021: 32022Jan 2022: 7Feb 2022: 4Mar 2022: 2Apr 2022: 2May 2022: 3Jun 2022: 0Jul 2022: 6Aug 2022: 6Sep 2022: 2Oct 2022: 0Nov 2022: 3Dec 2022: 32023Jan 2023: 1Feb 2023: 3Mar 2023: 2Apr 2023: 3May 2023: 3Jun 2023: 6Jul 2023: 5Aug 2023: 7Sep 2023: 1Oct 2023: 4Nov 2023: 4Dec 2023: 42024Jan 2024: 5Feb 2024: 2Mar 2024: 1Apr 2024: 1May 2024: 4Jun 2024: 1Jul 2024: 1Aug 2024: 1Sep 2024: 2Oct 2024: 4Nov 2024: 2Dec 2024: 12025Jan 2025: 0Feb 2025: 1Mar 2025: 3Apr 2025: 2May 2025: 1Jun 2025: 0Jul 2025: 2Aug 2025: 0Sep 2025: 1Oct 2025: 1Nov 2025: 1Dec 2025: 02026Jan 2026: 0Feb 2026: 1Mar 2026: 0Apr 2026: 1May 2026: 0Jun 2026: 0Jul 2026: 1Aug 2026: 0

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

02154302012: 420122013: 4302014: 14620142015: 1012016: 15220162017: 1302018: 11320182019: 1172020: 8520202021: 772022: 3820222023: 432024: 2520242025: 122026: 32026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.3%4
Malfunction99.7%1,472
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,476
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 28,222 reports carrying product code HBC. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Overheating of device49633.6%24.2%
Vibration23015.6%6.9%
Excessive heating21914.8%7.6%
Breakthe device broke18512.5%13.6%
Device operates differently than expectedthe device behaved unexpectedly926.2%7.5%
Temperature problem906.1%3.7%
Device inoperablethe device could not be used553.7%4.5%
Naturally worn523.5%1.7%
Difficult to insertthe device was hard to insert312.1%1.2%
Complete loss of power292%0.9%
Noise, audible292%4%
Detachment of device or device componentpart of the device came off271.8%2.3%
Sticking261.8%0.9%
Detachment of device component241.6%1.6%
Corrodedthe device corroded211.4%0.5%
Defective devicethe device was defective171.2%0.9%
Device slipped171.2%1%
Fitting problem171.2%0.7%
Mechanical jam140.9%0.4%
Application interface becomes non-functional or program exits abnormally130.9%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)ReportsShare
No patient involvement25317.1%
Burn(s)a burn20.1%
Injurya physical injury10.1%

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

In context

Measure8cm Angle AttachmentProduct code HBCAll MAUDE reports
Reports1,47628,22226,136,888
Share of that pool—5.2%0%
Classified as death, per 1,000 reports009
Classified as injury0.3%0.9%36.2%
Classified as malfunction99.7%98.9%62.3%
Filed by the manufacturer100%99.9%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 HBC

BrandReportsLatest 12 monthsClassified as death
Emax 2 Plus Motor8,860620%
11cm Angle Attachment2,10130%
6 5cm Adult Crani Attachmt2,108410%
Emax 2 Motor1,10500%
High Speed Elec G1 Handpiece Air Cooled1,317250.1%
5 0cm Short Attachment95300%
5 0 Cm Short Attachment99190%
11 0 Cm Long Attachment78500%
Adult Craniotome54590.2%
System Console46100%
Midas Rex MR87,2626,4160%
11 Cm Medium Qd Angle Attachment422100%
14cm Angle Attachment37600%
8 0 Cm Medium Attachment34800%
Pediatric Craniotome26500%

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 8cm Angle Attachment reports

How many FDA reports name 8cm Angle Attachment?

1,476 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.

What kinds of events are reported?

malfunction (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

overheating of device (33.6%), vibration (15.6%), excessive heating (14.8%), break (12.5%) and device operates differently than expected (6.2%). 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 8cm Angle Attachment 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.