| Device Type ID | 4488 |
| Device Name | Extractor |
| 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 | HWB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4488 |
| Device | Extractor |
| Product Code | HWB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 455 |
Bent | 41 |
Fracture | 41 |
Appropriate Term/Code Not Available | 41 |
Material Fragmentation | 33 |
Material Twisted / Bent | 29 |
Material Deformation | 20 |
Device-Device Incompatibility | 18 |
Naturally Worn | 17 |
Dull, Blunt | 14 |
Device Operates Differently Than Expected | 14 |
Crack | 13 |
Mechanical Jam | 12 |
Loose Or Intermittent Connection | 9 |
Metal Shedding Debris | 9 |
Connection Problem | 7 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Fitting Problem | 6 |
Device Issue | 5 |
Insufficient Information | 5 |
Difficult To Remove | 5 |
Disassembly | 4 |
Device Damaged By Another Device | 4 |
Entrapment Of Device | 3 |
Component Missing | 3 |
Corroded | 2 |
Material Integrity Problem | 2 |
Failure To Align | 2 |
Detachment Of Device Or Device Component | 2 |
Mechanical Problem | 2 |
Peeled / Delaminated | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Unintended Movement | 1 |
Physical Resistance / Sticking | 1 |
Incomplete Or Inadequate Connection | 1 |
Component Or Accessory Incompatibility | 1 |
Misassembly By Users | 1 |
Difficult To Position | 1 |
Separation Problem | 1 |
Material Distortion | 1 |
Positioning Problem | 1 |
Scratched Material | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Device Dislodged Or Dislocated | 1 |
Tip | 1 |
Loss Of Or Failure To Bond | 1 |
Shaft | 1 |
| Total Device Problems | 843 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes, Inc. | II | Apr-25-2018 |