| Device Type ID | 3702 |
| Device Name | Motor, Drill, Pneumatic |
| Regulation Description | Pneumatic Cranial Drill Motor. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3702 |
| Device | Motor, Drill, Pneumatic |
| Product Code | HBB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Pneumatic Cranial Drill Motor. |
| CFR Regulation Number | 882.4370 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Output Below Specifications | 152 |
Leak / Splash | 140 |
Overheating Of Device | 100 |
Bent | 81 |
Unintended System Motion | 71 |
Fail-Safe Problem | 64 |
Noise, Audible | 63 |
Device Abrasion From Instrument Or Another Object | 44 |
Unintended Power Up | 35 |
Fluid Leak | 30 |
Device Operates Differently Than Expected | 24 |
Disassembly | 21 |
Device Inoperable | 17 |
Material Puncture / Hole | 13 |
Detachment Of Device Or Device Component | 12 |
Device Remains Activated | 9 |
Air Leak | 7 |
Unintended Movement | 6 |
Mechanical Problem | 6 |
Fracture | 6 |
Detachment Of Device Component | 5 |
Sticking | 4 |
Motor | 4 |
Mechanical Jam | 4 |
Burst Container Or Vessel | 4 |
Vibration | 3 |
Hose | 3 |
Unexpected Shutdown | 3 |
Hole In Material | 3 |
Fitting Problem | 3 |
Break | 3 |
Material Rupture | 3 |
Housing | 2 |
Device Slipped | 2 |
Partial Blockage | 2 |
Material Deformation | 2 |
Loss Of Power | 2 |
Metal Shedding Debris | 2 |
Device Operational Issue | 2 |
Migration Or Expulsion Of Device | 2 |
Difficult To Remove | 1 |
Physical Resistance | 1 |
Material Twisted / Bent | 1 |
Cutter | 1 |
Power Problem | 1 |
Handpiece | 1 |
Unstable | 1 |
Corroded | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Device Stops Intermittently | 1 |
Device Dislodged Or Dislocated | 1 |
Failure To Auto Stop | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Smoking | 1 |
Melted | 1 |
No Apparent Adverse Event | 1 |
Material Fragmentation | 1 |
Pressure Problem | 1 |
Device-Device Incompatibility | 1 |
Defective Device | 1 |
Naturally Worn | 1 |
No Fail-Safe Mechanism | 1 |
Component Falling | 1 |
Flaked | 1 |
Difficult To Insert | 1 |
Positioning Problem | 1 |
Switch, Push Button | 1 |
| Total Device Problems | 987 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap Implant Systems LLC | II | Feb-15-2018 |
| 2 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | II | May-04-2016 |
| 3 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | II | Nov-20-2015 |
| 4 | Stryker Instruments Div. Of Stryker Corporation | II | Jun-09-2016 |
| 5 | The Anspach Effort, Inc. | II | Jun-25-2014 |
| 6 | The Anspach Effort, Inc. | II | Jan-09-2014 |