| Device Type ID | 4481 |
| Device Name | Broach |
| 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 | HTQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4481 |
| Device | Broach |
| Product Code | HTQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 160 |
Appropriate Term/Code Not Available | 142 |
Loose Or Intermittent Connection | 81 |
Naturally Worn | 65 |
Device-Device Incompatibility | 64 |
Connection Problem | 64 |
Scratched Material | 31 |
Component Missing | 28 |
Material Deformation | 27 |
Fracture | 22 |
Bent | 20 |
Insufficient Information | 16 |
Fitting Problem | 15 |
Mechanical Problem | 13 |
Crack | 12 |
Inadequacy Of Device Shape And/or Size | 7 |
Mechanical Jam | 5 |
Difficult To Remove | 5 |
Misconnection | 4 |
Device Issue | 4 |
Incomplete Or Inadequate Connection | 4 |
Difficult To Insert | 4 |
Entrapment Of Device | 3 |
Material Twisted / Bent | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Deformation Due To Compressive Stress | 2 |
Disassembly | 2 |
Dull, Blunt | 2 |
Separation Problem | 2 |
Defective Device | 2 |
Blocked Connection | 2 |
Unintended Movement | 2 |
Physical Resistance / Sticking | 2 |
Loosening Of Implant Not Related To Bone-Ingrowth | 1 |
Difficult To Position | 1 |
Failure To Disconnect | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Positioning Problem | 1 |
Material Disintegration | 1 |
Solder Joint Fracture | 1 |
Compatibility Problem | 1 |
| Total Device Problems | 826 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Greatbatch Medical | II | May-09-2017 |