| Device Type ID | 4502 |
| Device Name | Tap, Bone |
| 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 | HWX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4502 |
| Device | Tap, Bone |
| Product Code | HWX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 123 |
Fracture | 20 |
Material Fragmentation | 15 |
Contamination / Decontamination Problem | 14 |
Device-Device Incompatibility | 7 |
Device Contamination With Chemical Or Other Material | 5 |
Crack | 3 |
Difficult To Insert | 3 |
Component Missing | 3 |
Failure To Adhere Or Bond | 3 |
Difficult To Remove | 2 |
Device Operates Differently Than Expected | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Material Deformation | 2 |
Material Separation | 2 |
Mechanical Jam | 1 |
Unintended Movement | 1 |
Physical Resistance / Sticking | 1 |
Detachment Of Device Component | 1 |
Device Or Device Fragments Location Unknown | 1 |
Tip | 1 |
Particulates | 1 |
Use Of Device Problem | 1 |
Material Twisted / Bent | 1 |
Migration Or Expulsion Of Device | 1 |
| Total Device Problems | 216 |