Devices › Motor, drill, electric
Device brand name · Motor drill electric - attachment
11cm Angle Attachment: medical device reports filed with FDA
2,101 reports name it, 2013–2025. Manufacturer given most often on reports: Depuy Synthes Power Tools. Product code HBC.
- 2,101
- device reports naming the brand
- 0% of all MAUDE reports · about 156 a year
- 3
- reports, 12 months to August 2026
- 31 in the 12 months before
- 99.6%
- 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 2,101 reports that name the brand "11cm Angle Attachment" (motor drill electric - attachment), received between January 2013 and November 2025; the manufacturer given most often on reports is Depuy Synthes Power Tools. Spellings of one product vary from report to report.
3 reports arrived in the 12 months to August 2026, down 90% from 31 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 (99.6%) and injury (0.2%); 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 (34.8%), excessive heating (16.5%) and vibration (14.3%). The patient problems coded most often are no patient involvement, apnea and foreign body in patient. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
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) | Reports | Share | Share across product code |
|---|---|---|---|
| Overheating of device | 731 | 34.8% | 24.2% |
| Excessive heating | 346 | 16.5% | 7.6% |
| Vibration | 300 | 14.3% | 6.9% |
| Breakthe device broke | 262 | 12.5% | 13.6% |
| Temperature problem | 133 | 6.3% | 3.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 113 | 5.4% | 7.5% |
| Naturally worn | 94 | 4.5% | 1.7% |
| Device inoperablethe device could not be used | 90 | 4.3% | 4.5% |
| Noise, audible | 60 | 2.9% | 4% |
| Difficult to insertthe device was hard to insert | 48 | 2.3% | 1.2% |
| Defective component | 38 | 1.8% | 0.6% |
| Loose or intermittent connection | 35 | 1.7% | 0.7% |
| Defective devicethe device was defective | 32 | 1.5% | 0.9% |
| Detachment of device or device componentpart of the device came off | 32 | 1.5% | 2.3% |
| Corrodedthe device corroded | 31 | 1.5% | 0.5% |
| Complete loss of power | 29 | 1.4% | 0.9% |
| Detachment of device component | 28 | 1.3% | 1.6% |
| Mechanical problema mechanical problem | 26 | 1.2% | 1.2% |
| Sticking | 23 | 1.1% | 0.9% |
| Device slipped | 20 | 1% | 1% |
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 | 426 | 20.3% |
| Apnea | 1 | 0% |
| Foreign body in patientpart of a device left in the patient | 1 | 0% |
| Partial thickness (second degree) burn | 1 | 0% |
| Sleep dysfunction | 1 | 0% |
| Swellingswelling | 1 | 0% |
| Tissue damage | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 11cm Angle Attachment | Product code HBC | All MAUDE reports |
|---|---|---|---|
| Reports | 2,101 | 28,222 | 26,136,888 |
| Share of that pool | — | 7.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.2% | 0.9% | 36.2% |
| Classified as malfunction | 99.6% | 98.9% | 62.3% |
| Filed by the manufacturer | 100% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Emax 2 Plus Motor | 8,860 | 62 | 0% |
| 6 5cm Adult Crani Attachmt | 2,108 | 41 | 0% |
| 8cm Angle Attachment | 1,476 | 6 | 0% |
| Emax 2 Motor | 1,105 | 0 | 0% |
| High Speed Elec G1 Handpiece Air Cooled | 1,317 | 25 | 0.1% |
| 5 0cm Short Attachment | 953 | 0 | 0% |
| 5 0 Cm Short Attachment | 991 | 9 | 0% |
| 11 0 Cm Long Attachment | 785 | 0 | 0% |
| Adult Craniotome | 545 | 9 | 0.2% |
| System Console | 461 | 0 | 0% |
| Midas Rex MR8 | 7,262 | 6,416 | 0% |
| 11 Cm Medium Qd Angle Attachment | 422 | 10 | 0% |
| 14cm Angle Attachment | 376 | 0 | 0% |
| 8 0 Cm Medium Attachment | 348 | 0 | 0% |
| Pediatric Craniotome | 265 | 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 11cm Angle Attachment reports
How many FDA reports name 11cm Angle Attachment?
2,101 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
malfunction (99.6%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
overheating of device (34.8%), excessive heating (16.5%), vibration (14.3%), break (12.5%) and temperature problem (6.3%). 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 11cm 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.