Devices › Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Device brand name · Instrument surgical orthopedic ac-powered motor and accessory/attachment
Unium Modular Handpiece: medical device reports filed with FDA
403 reports name it, 2022–2026. Manufacturer given most often on reports: Synthes. Product code HWE.
- 403
- device reports naming the brand
- 0% of all MAUDE reports · about 90 a year
- 137
- reports, 12 months to August 2026
- 126 in the 12 months before
- 100%
- classified as malfunction
- 97.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
403 medical device reports received by FDA name the brand "Unium Modular Handpiece" (instrument surgical orthopedic ac-powered motor and accessory/attachment); the manufacturer given most often on reports is Synthes; received from January 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
137 reports arrived in the 12 months to August 2026, close to the 126 of 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 (100%); across all instrument, surgical, orthopedic, ac-powered motor and accessory/attachment reports (product code HWE) death is recorded in 0% and malfunction in 97.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are physical resistance/sticking (40.4%), device slipped (20.6%) and intermittent loss of power (16.4%). 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 50,440 reports carrying product code HWE. 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 |
|---|---|---|---|
| Physical resistance/sticking | 163 | 40.4% | 10.2% |
| Device slipped | 83 | 20.6% | 0.8% |
| Intermittent loss of power | 66 | 16.4% | 1.5% |
| Complete loss of power | 55 | 13.6% | 7.5% |
| Detachment of device or device componentpart of the device came off | 42 | 10.4% | 2.9% |
| Mechanical jam | 37 | 9.2% | 13.1% |
| Output below specifications | 37 | 9.2% | 5.2% |
| Leak/splashthe device leaked | 14 | 3.5% | 1.2% |
| Noise, audible | 14 | 3.5% | 6.1% |
| Premature separation | 13 | 3.2% | 0.4% |
| Unintended system motionthe device moved when it should not have | 10 | 2.5% | 6.3% |
| Excessive heating | 9 | 2.2% | 3.5% |
| Breakthe device broke | 8 | 2% | 8.2% |
| Material fragmentation | 6 | 1.5% | 0.9% |
| Component missing | 5 | 1.2% | 0.5% |
| Improper or incorrect procedure or method | 5 | 1.2% | 0.1% |
| Device reprocessing problem | 2 | 0.5% | 0.1% |
| Device-device incompatibility | 2 | 0.5% | 1.3% |
| Difficult or delayed separation | 2 | 0.5% | 0.1% |
| Intermittent energy output | 2 | 0.5% | 0.4% |
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.
In context
| Measure | Unium Modular Handpiece | Product code HWE | All MAUDE reports |
|---|---|---|---|
| Reports | 403 | 50,440 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 2.3% | 36.2% |
| Classified as malfunction | 100% | 97.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 HWE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Small Battery Drive | 2,439 | 0 | 0% |
| Colibri | 1,472 | 0 | 0% |
| Electric Pen Drive 60 000 Rpm | 1,486 | 94 | 0% |
| Sagittal Saw Attachment | 1,505 | 64 | 0% |
| Smartlife Large Aspetic Housing | 1,132 | 2 | 0% |
| Sagittal Saw Attachment Long For Trs | 1,039 | 90 | 0% |
| Quick Coupling For K-Wires | 744 | 28 | 0% |
| Epd 60000 Rpm | 737 | 0 | 0% |
| Air Oscillator | 657 | 0 | 0% |
| Chuck With Key/Drill Speed For Trs | 655 | 94 | 0% |
| Small Battery Drive Colibri | 633 | 0 | 0% |
| Modular Calcar Planer Sml | 515 | 30 | 0% |
| Sagittal Saw Attachment For Trs | 428 | 77 | 0% |
| System 6 Sagittal Saw | 698 | 0 | 0% |
| Modified Hudson Adapter | 425 | 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 Unium Modular Handpiece reports
How many FDA reports name Unium Modular Handpiece?
403 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 137 in the latest 12 months.
What kinds of events are reported?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
physical resistance/sticking (40.4%), device slipped (20.6%), intermittent loss of power (16.4%), complete loss of power (13.6%) and detachment of device or device component (10.4%). 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 Unium Modular Handpiece 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.