MAUDE manufacturer profile
DEPUY SYNTHES POWER TOOLS · HBE
MAUDE profile for Drills, Burrs, Trephines & Accessories (Simple, Powered)
Key facts
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
|---|---|
| Manufacturer group | DEPUY SYNTHES POWER TOOLS |
| Product code | HBE |
| Product code name | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Patient Involvement, Overheating of Device, Break, Device Operates Differently Than Expected, Mechanical Problem, Device Inoperable, Temperature Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1