| Device Type ID | 5581 |
| Device Name | Hammer, Surgical |
| Regulation Description | Manual Surgical Instrument For General Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FZY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5581 |
| Device | Hammer, Surgical |
| Product Code | FZY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 86 |
Device Contamination With Chemical Or Other Material | 39 |
Residue After Decontamination | 26 |
Leak / Splash | 15 |
Appropriate Term/Code Not Available | 14 |
Fracture | 11 |
Disassembly | 9 |
Material Deformation | 8 |
Naturally Worn | 6 |
Connection Problem | 6 |
Bent | 5 |
Component Missing | 4 |
Crack | 4 |
Dull, Blunt | 3 |
Contamination / Decontamination Problem | 3 |
Device Operates Differently Than Expected | 3 |
Metal Shedding Debris | 2 |
Entrapment Of Device | 2 |
Failure To Align | 2 |
Insufficient Information | 2 |
Device-Device Incompatibility | 2 |
Mechanical Jam | 2 |
Dent In Material | 1 |
Detachment Of Device Or Device Component | 1 |
Device Damaged Prior To Use | 1 |
Material Distortion | 1 |
Positioning Problem | 1 |
Component Falling | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Difficult To Maintain | 1 |
Material Twisted / Bent | 1 |
Material Disintegration | 1 |
Failure To Adhere Or Bond | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 266 |