| Device Type ID | 4517 |
| Device Name | Screwdriver |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| 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 | 888.4540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HXX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4517 |
| Device | Screwdriver |
| Product Code | HXX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 2264 |
Fracture | 360 |
Dull, Blunt | 244 |
Naturally Worn | 222 |
Material Deformation | 220 |
Material Twisted / Bent | 217 |
Appropriate Term/Code Not Available | 193 |
Material Fragmentation | 175 |
Device Operates Differently Than Expected | 145 |
Bent | 94 |
Device-Device Incompatibility | 90 |
Device Contamination With Chemical Or Other Material | 53 |
Crack | 51 |
Peeled / Delaminated | 39 |
Failure To Adhere Or Bond | 39 |
Contamination / Decontamination Problem | 33 |
Mechanical Problem | 30 |
Fitting Problem | 27 |
Mechanical Jam | 21 |
Material Distortion | 19 |
Delivered As Unsterile Product | 19 |
Tip | 18 |
Adverse Event Without Identified Device Or Use Problem | 16 |
Material Integrity Problem | 16 |
Loose Or Intermittent Connection | 16 |
Disassembly | 15 |
Screw | 14 |
Component Missing | 14 |
Difficult To Remove | 14 |
Insufficient Information | 14 |
Detachment Of Device Component | 13 |
Connection Problem | 10 |
Continuous Firing | 9 |
Device Slipped | 9 |
Detachment Of Device Or Device Component | 9 |
Failure To Shut Off | 9 |
Device Damaged Prior To Use | 9 |
Driver | 7 |
Device Inoperable | 7 |
Device Stops Intermittently | 6 |
Use Of Device Problem | 6 |
Material Split, Cut Or Torn | 5 |
Device Difficult To Maintain | 5 |
Failure To Align | 5 |
Sticking | 5 |
Device Handling Problem | 5 |
Material Separation | 5 |
Device Issue | 5 |
Unsealed Device Packaging | 4 |
Defective Device | 4 |
Device Or Device Fragments Location Unknown | 4 |
Packaging Problem | 4 |
Failure To Disconnect | 4 |
Shipping Damage Or Problem | 4 |
Device Dislodged Or Dislocated | 4 |
Corroded | 4 |
Material Discolored | 3 |
Device Operational Issue | 3 |
Shaft | 3 |
Device Remains Activated | 3 |
Device Markings / Labelling Problem | 3 |
Manufacturing, Packaging Or Shipping Problem | 3 |
Torn Material | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Physical Resistance / Sticking | 3 |
Dent In Material | 2 |
Contamination Of Device Ingredient Or Reagent | 2 |
Failure To Power Up | 2 |
Calibration Problem | 2 |
Fluid Leak | 2 |
Separation Problem | 2 |
Mechanics Altered | 2 |
Calibration Error | 2 |
Electrical /Electronic Property Problem | 2 |
Output Above Specifications | 2 |
Structural Problem | 2 |
Metal Shedding Debris | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Defective Component | 2 |
Failure To Advance | 1 |
Compatibility Problem | 1 |
Misconnection | 1 |
Guidewire | 1 |
Power Problem | 1 |
Handpiece | 1 |
Device Fell | 1 |
Device Component Or Accessory | 1 |
Device Reprocessing Problem | 1 |
Material Disintegration | 1 |
Failure To Calibrate | 1 |
Loss Of Or Failure To Bond | 1 |
Particulates | 1 |
Failure To Recalibrate | 1 |
Deformation Due To Compressive Stress | 1 |
Circuit Breaker | 1 |
Failure To Run On Battery | 1 |
Unraveled Material | 1 |
Residue After Decontamination | 1 |
Component Falling | 1 |
Entrapment Of Device | 1 |
| Total Device Problems | 4929 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ebi, Llc | II | Jun-17-2014 |
| 2 | Greatbatch Medical | II | Jun-01-2016 |
| 3 | Medtronic Sofamor Danek USA Inc | II | Jan-30-2014 |
| 4 | Orthofix, Inc | II | Jun-01-2016 |
| 5 | Synthes (USA) Products LLC | II | May-23-2018 |