| Device Type ID | 4629 |
| Device Name | Accessories, Arthroscopic |
| Regulation Description | Arthroscope. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.1100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NBH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4629 |
| Device | Accessories, Arthroscopic |
| Product Code | NBH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Arthroscope. |
| CFR Regulation Number | 888.1100 [🔎] |
| Device Problems | |
|---|---|
Break | 101 |
Detachment Of Device Or Device Component | 31 |
Material Twisted / Bent | 27 |
Fracture | 15 |
Material Deformation | 10 |
Device Operates Differently Than Expected | 9 |
Detachment Of Device Component | 8 |
Needle | 7 |
Material Fragmentation | 6 |
Mechanical Jam | 6 |
Tip | 6 |
Material Separation | 5 |
Device Contamination With Chemical Or Other Material | 5 |
Deformation Due To Compressive Stress | 3 |
Retraction Problem | 3 |
Use Of Device Problem | 2 |
Metal Shedding Debris | 2 |
Misfire | 2 |
Cannula | 2 |
Difficult To Remove | 2 |
Guidewire | 2 |
Pin | 2 |
Device Inoperable | 2 |
Material Integrity Problem | 2 |
Physical Resistance / Sticking | 2 |
Knife | 2 |
Component Falling | 2 |
Loose Or Intermittent Connection | 1 |
Dull, Blunt | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Separation Problem | 1 |
Torn Material | 1 |
Crack | 1 |
Mechanical Problem | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Load | 1 |
Unintended Collision | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Sticking | 1 |
Intermittent Loss Of Power | 1 |
Unexpected Shutdown | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Contamination With Body Fluid | 1 |
Failure To Adhere Or Bond | 1 |
Corroded | 1 |
Bent | 1 |
Suture | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Shaft | 1 |
Jaw | 1 |
Material Frayed | 1 |
Component Missing | 1 |
Difficult To Open Or Close | 1 |
Material Split, Cut Or Torn | 1 |
| Total Device Problems | 294 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ceterix Orthopedics, Inc. | II | Aug-28-2018 |
| 2 | Ceterix Orthopedics, Inc. | II | Nov-09-2015 |
| 3 | Smith & Nephew, Inc. | II | Jul-18-2016 |
| 4 | Smith & Nephew, Inc. | II | Feb-10-2016 |
| 5 | Smith & Nephew, Inc., Endoscopy Div. | II | Feb-18-2016 |
| 6 | Smith & Nephew, Inc., Endoscopy Div. | II | Jan-29-2016 |
| 7 | Stryker Corporation | II | Jun-03-2016 |