| Device Type ID | 3705 |
| Device Name | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Regulation Description | Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories. |
| 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 | 882.4310 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBE |
| 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 | 3705 |
| Device | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Product Code | HBE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories. |
| CFR Regulation Number | 882.4310 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADEOR MEDICAL AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AD-TECH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AD-TECH MEDICAL INSTRUMENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOTEX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MRI INTERVENTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEOMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Overheating Of Device | 1036 |
Flaked | 584 |
Break | 420 |
Fracture | 153 |
Disassembly | 94 |
Bent | 82 |
Vibration | 50 |
Detachment Of Device Or Device Component | 38 |
Device Operates Differently Than Expected | 28 |
Device Inoperable | 25 |
Mechanical Problem | 24 |
Noise, Audible | 21 |
Detachment Of Device Component | 20 |
Material Twisted / Bent | 18 |
Material Fragmentation | 15 |
Leak / Splash | 12 |
Device Displays Incorrect Message | 12 |
Sticking | 11 |
Fluid Leak | 11 |
Temperature Problem | 9 |
Material Separation | 9 |
Difficult To Remove | 8 |
Smoking | 7 |
Packaging Problem | 7 |
Difficult To Position | 6 |
Tip | 6 |
Self-Activation Or Keying | 6 |
Cutter | 6 |
Defective Component | 5 |
Unintended System Motion | 5 |
Device Remains Activated | 5 |
Bearings | 5 |
Use Of Device Problem | 4 |
Metal Shedding Debris | 4 |
Shaft | 4 |
Connection Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Unstable | 3 |
Material Disintegration | 3 |
Difficult To Insert | 3 |
Dull, Blunt | 3 |
Mechanical Jam | 3 |
Peeled / Delaminated | 2 |
Material Deformation | 2 |
Unintended Movement | 2 |
Loose Or Intermittent Connection | 2 |
Failure To Adhere Or Bond | 2 |
Output Below Specifications | 2 |
Unintended Power Up | 2 |
Delivered As Unsterile Product | 2 |
Component Missing | 2 |
No Apparent Adverse Event | 2 |
Deformation Due To Compressive Stress | 1 |
Misfire | 1 |
Contamination / Decontamination Problem | 1 |
Ventilation Problem In Device Environment | 1 |
Fail-Safe Problem | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Device Stops Intermittently | 1 |
Material Integrity Problem | 1 |
Handpiece | 1 |
Ambient Noise Problem | 1 |
Biocompatibility | 1 |
Device Markings / Labelling Problem | 1 |
Positioning Problem | 1 |
Device Alarm System | 1 |
Thermal Decomposition Of Device | 1 |
Component Falling | 1 |
Computer Software Problem | 1 |
Naturally Worn | 1 |
Gears | 1 |
Charred | 1 |
Insufficient Information | 1 |
Device Subassembly | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fitting Problem | 1 |
Cover | 1 |
Guide | 1 |
Partial Blockage | 1 |
Locking Mechanism | 1 |
Tube | 1 |
Material Protrusion / Extrusion | 1 |
Failure To Power Up | 1 |
| Total Device Problems | 2825 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ad-Tech Medical Instrument Corporation | II | Jul-25-2018 |
| 2 | Aesculap Implant Systems LLC | II | Feb-15-2018 |
| 3 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 4 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | II | Jun-28-2016 |
| 5 | Stryker Instruments Div. Of Stryker Corporation | II | Dec-21-2016 |
| 6 | Stryker Instruments Div. Of Stryker Corporation | II | Jul-19-2016 |
| 7 | Stryker Instruments Div. Of Stryker Corporation | II | Jul-14-2016 |
| 8 | Stryker Instruments Div. Of Stryker Corporation | II | Jun-11-2014 |
| 9 | The Anspach Effort, Inc. | II | May-04-2017 |
| 10 | The Anspach Effort, Inc. | II | Sep-16-2016 |
| 11 | The Anspach Effort, Inc. | II | Jul-29-2015 |
| 12 | The Anspach Effort, Inc. | II | Jun-25-2014 |
| 13 | The Anspach Effort, Inc. | II | Jan-15-2014 |
| 14 | The Anspach Effort, Inc. | II | Jan-13-2014 |
| 15 | The Anspach Effort, Inc. | II | Jan-10-2014 |
| 16 | The Anspach Effort, Inc. | II | Jan-09-2014 |