Device Type ID | 5665 |
Device Name | Saw, Powered, And Accessories |
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 | HAB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5665 |
Device | Saw, Powered, And Accessories |
Product Code | HAB |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
CFR Regulation Number | 878.4820 [🔎] |
Device Problems | |
---|---|
Overheating Of Device | 72 |
Sparking | 27 |
Metal Shedding Debris | 24 |
Break | 11 |
Electrical /Electronic Property Problem | 10 |
Device Operates Differently Than Expected | 9 |
Smoking | 7 |
Knife | 6 |
Device Inoperable | 5 |
Handpiece | 5 |
Activation, Positioning Or Separation Problem | 4 |
Device Remains Activated | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Temperature Problem | 4 |
Noise, Audible | 4 |
Device Contamination With Chemical Or Other Material | 3 |
Material Fragmentation | 3 |
Unintended Power Up | 3 |
Self-Activation Or Keying | 3 |
Unintended Movement | 2 |
Detachment Of Device Or Device Component | 2 |
Failure To Shut Off | 2 |
Thermal Decomposition Of Device | 2 |
Loose Or Intermittent Connection | 2 |
Insufficient Information | 1 |
Fluid Leak | 1 |
Cut In Material | 1 |
Battery Charger, Defective | 1 |
Partial Blockage | 1 |
Detachment Of Device Component | 1 |
Leak / Splash | 1 |
Fitting Problem | 1 |
Loss Of Power | 1 |
Device Issue | 1 |
Mechanical Jam | 1 |
Unclear Information | 1 |
Device Displays Incorrect Message | 1 |
Connection Problem | 1 |
Shaft | 1 |
Tip | 1 |
Melted | 1 |
Component Missing | 1 |
Pin | 1 |
Corroded | 1 |
Vibration | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Power Problem | 1 |
Device Operational Issue | 1 |
Total Device Problems | 242 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Arthrex, Inc. | II | Oct-30-2018 |
2 | Smith & Nephew, Inc. | II | Feb-22-2017 |
3 | Zimmer Biomet, Inc. | II | Oct-26-2016 |
4 | Zimmer Surgical Inc | II | Oct-31-2014 |
5 | Zimmer, Inc. | II | Dec-21-2015 |