| Device Type ID | 4516 |
| Device Name | Bender |
| 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 | HXW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4516 |
| Device | Bender |
| Product Code | HXW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Fracture | 42 |
Break | 19 |
Device Inoperable | 16 |
Disassembly | 15 |
Device Operates Differently Than Expected | 4 |
Sticking | 4 |
Device Operational Issue | 3 |
Detachment Of Device Or Device Component | 2 |
Naturally Worn | 2 |
Defective Device | 1 |
Loose Or Intermittent Connection | 1 |
Unintended Movement | 1 |
Physical Resistance / Sticking | 1 |
Device Maintenance Issue | 1 |
Material Fragmentation | 1 |
Separation Failure | 1 |
Mechanical Jam | 1 |
Migration Or Expulsion Of Device | 1 |
Pin | 1 |
Component Missing | 1 |
| Total Device Problems | 118 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes, Inc. | II | Jan-28-2015 |