| Device Type ID | 5656 |
| Device Name | Blade, Saw, General & Plastic Surgery, Surgical |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GFA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5656 |
| Device | Blade, Saw, General & Plastic Surgery, Surgical |
| Product Code | GFA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Break | 261 |
Device Operates Differently Than Expected | 102 |
Device Inoperable | 32 |
Fracture | 31 |
Mechanical Problem | 27 |
Packaging Problem | 20 |
Vibration | 19 |
Detachment Of Device Component | 18 |
Bent | 16 |
Noise, Audible | 12 |
Overheating Of Device | 11 |
Material Deformation | 11 |
Material Fragmentation | 11 |
Cable | 11 |
Shaft | 10 |
Motor | 10 |
Device Slipped | 8 |
Knife | 8 |
Device Contamination With Chemical Or Other Material | 7 |
Tip | 7 |
Protector | 6 |
Output Below Specifications | 6 |
Device Operational Issue | 6 |
Crack | 6 |
Detachment Of Device Or Device Component | 6 |
Component Falling | 5 |
Failure To Power Up | 5 |
Difficult To Remove | 5 |
Pin | 4 |
Corroded | 4 |
Component Missing | 4 |
Material Separation | 4 |
Mechanical Jam | 4 |
Loose Or Intermittent Connection | 4 |
SAW (Surface Acoustic Wave Device) | 4 |
Difficult To Position | 4 |
Naturally Worn | 3 |
Temperature Problem | 3 |
Dull, Blunt | 3 |
Material Protrusion / Extrusion | 3 |
Connection Problem | 3 |
Self-Activation Or Keying | 3 |
Defective Component | 3 |
Material Twisted / Bent | 3 |
Material Integrity Problem | 2 |
Handpiece | 2 |
Failure To Service | 2 |
Contamination / Decontamination Problem | 2 |
Delivered As Unsterile Product | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Metal Shedding Debris | 2 |
Device Packaging Compromised | 2 |
Failure To Disconnect | 2 |
Failure To Align | 2 |
Fluid Leak | 2 |
Device Or Device Fragments Location Unknown | 2 |
Gears | 2 |
Device Expiration Issue | 1 |
Stretched | 1 |
Defective Device | 1 |
Malposition Of Device | 1 |
Positioning Problem | 1 |
Device Damaged Prior To Use | 1 |
Disconnection | 1 |
Bushing | 1 |
Unclear Information | 1 |
Transducer Overheating | 1 |
Unsealed Device Packaging | 1 |
Loss Of Power | 1 |
Power Cord | 1 |
Partial Blockage | 1 |
Peeled / Delaminated | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Sticking | 1 |
Failure To Cut | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Screw | 1 |
Bearings | 1 |
Disassembly | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
Retraction Problem | 1 |
Use Of Device Problem | 1 |
Fail-Safe Problem | 1 |
Device Remains Activated | 1 |
Furnace | 1 |
Material Frayed | 1 |
Device Stops Intermittently | 1 |
Failure To Adhere Or Bond | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Unstable | 1 |
Compatibility Problem | 1 |
Human-Device Interface Problem | 1 |
Foot Switch | 1 |
Material Disintegration | 1 |
| Total Device Problems | 796 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Sustainability Solutions | II | Nov-06-2015 |
| 2 | Synvasive Technology Inc | II | Dec-22-2015 |