Device manufacturer, as written on reports
Depuy Synthes Products: medical device reports filed with FDA
24,793 reports name it as the manufacturer of the device involved, 2017–2026.
- 24,793
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 264
- reports, 12 months to August 2026
- 839 in the 12 months before
- 99.4%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
24,793 medical device reports received by FDA give Depuy Synthes Products as the manufacturer of the device involved, 0.1% of the MAUDE database, from October 2017 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
264 reports arrived in the 12 months to August 2026, down 69% from 839 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 (99.4%) and injury (0.6%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Emax 2 Plus Motor | Motor, drill, electric | 3,405 | 62 | 0% |
| High Speed Elec G1 Handpiece Air Cooled | Motor, drill, electric | 1,073 | 25 | 0.1% |
| 6 5cm Adult Crani Attachmt | Motor, drill, electric | 1,039 | 41 | 0% |
| Battery Handpiece/Modular For Trs | Motor, surgical instrument, ac-powered | 965 | 213 | 0% |
| Motor Assembly Xmax | Drill, surgical, ent (electric or pneumatic) including handpiece | 883 | 14 | 0% |
| 11cm Angle Attachment | Motor, drill, electric | 778 | 3 | 0% |
| Xmax Motor | Drill, surgical, ent (electric or pneumatic) including handpiece | 713 | 0 | 0% |
| Small Battery Drive | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 595 | 0 | 0% |
| 8cm Angle Attachment | Motor, drill, electric | 516 | 6 | 0% |
| 5 0 Cm Short Attachment | Motor, drill, electric | 451 | 9 | 0% |
| Electric Pen Drive 60 000 Rpm | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 441 | 94 | 0% |
| Adult Craniotome | Motor, drill, electric | 436 | 9 | 0.2% |
| 11 Cm Medium Qd Angle Attachment | Motor, drill, electric | 385 | 10 | 0% |
| Air Pen Drive | Motor, drill, pneumatic | 382 | 22 | 0% |
| Kincise Automated Surgical Impactor | Motor, surgical instrument, ac-powered | 357 | 11 | 0% |
| Air Oscillator | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 339 | 0 | 0% |
| Sagittal Saw Attachment | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 238 | 64 | 0% |
| Compact Speed Reducer 60 1 | Drills, burrs, trephines & accessories (simple, powered) | 231 | 0 | 0% |
| Oscill-Saw | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 186 | 0 | 0% |
| 8 Cm Short Qd Angle Attachment | Motor, drill, electric | 173 | 1 | 0% |
| Kincise Pinnacle Shell/Liner Impactor | Motor, surgical instrument, ac-powered | 171 | 11 | 0% |
| 11 0 Cm Long Attachment | Motor, drill, electric | 130 | 0 | 0% |
| Power Module For Trauma Recon System | Battery, replacement, rechargeable | 125 | 51 | 0% |
| Battery Oscillator | Motor, surgical instrument, ac-powered | 122 | 0 | 0% |
| Quick Coupling For K-Wires | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 102 | 28 | 0% |
| Sagittal Saw Attachment Long For Trs | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 99 | 90 | 0% |
| 8 0 Cm Medium Attachment | Motor, drill, electric | 97 | 0 | 0% |
| Recon Sagittal Saw With Key For Trs | Motor, surgical instrument, ac-powered | 88 | 21 | 0% |
| Minimal Access Attachment | Drills, burrs, trephines & accessories (simple, powered) | 84 | 1 | 0% |
| 5 Cm Short Attachment | Motor, drill, electric | 76 | 5 | 0% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| HBC | Motor, drill, electric | 7,374 | 29.7% |
| HWE | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 7,346 | 29.6% |
| GEY | Motor, surgical instrument, ac-powered | 5,245 | 21.2% |
| ERL | Drill, surgical, ent (electric or pneumatic) including handpiece | 2,967 | 12% |
| HBE | Drills, burrs, trephines & accessories (simple, powered) | 959 | 3.9% |
| HBB | Motor, drill, pneumatic | 550 | 2.2% |
| MOQ | Battery, replacement, rechargeable | 226 | 0.9% |
| GFA | Blade, saw, general & plastic surgery, surgical | 63 | 0.3% |
| GFF | Bur, surgical, general & plastic surgery | 26 | 0.1% |
| HSZ | Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment | 18 | 0.1% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Depuy Synthes Products reports
How many FDA device reports name Depuy Synthes Products as manufacturer?
24,793 reports through August 2026, 264 of them in the latest 12 months.
Which of its brands appear most often?
Emax 2 Plus Motor (3,405), High Speed Elec G1 Handpiece Air Cooled (1,073), 6 5cm Adult Crani Attachmt (1,039), Battery Handpiece/Modular For Trs (965) and Motor Assembly Xmax (883).
Which device types does it report on?
motor, drill, electric (29.7%), instrument, surgical, orthopedic, ac-powered motor and accessory/attachment (29.6%), motor, surgical instrument, ac-powered (21.2%) and drill, surgical, ent (electric or pneumatic) including handpiece (12%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.