| Device Type ID | 5743 |
| Device Name | Instrument, Manual, Surgical, General Use |
| 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 | MDM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5743 |
| Device | Instrument, Manual, Surgical, General Use |
| Product Code | MDM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 186 |
Fracture | 161 |
Crack | 22 |
Insufficient Information | 22 |
Appropriate Term/Code Not Available | 21 |
Tip | 20 |
Screw | 13 |
Material Twisted / Bent | 12 |
Device Damaged By Another Device | 12 |
Detachment Of Device Component | 11 |
Device-Device Incompatibility | 11 |
Material Deformation | 11 |
Connection Problem | 11 |
Shaft | 9 |
Bent | 9 |
Fitting Problem | 8 |
Mechanical Jam | 8 |
Component Falling | 7 |
Device Contamination With Body Fluid | 7 |
Corroded | 6 |
Pad | 6 |
Disassembly | 6 |
Scratched Material | 6 |
Torn Material | 6 |
Thread | 6 |
Material Integrity Problem | 5 |
Bolt | 5 |
Difficult To Remove | 5 |
Device Operates Differently Than Expected | 5 |
Device Reprocessing Problem | 4 |
Use Of Device Problem | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Defective Device | 4 |
Naturally Worn | 4 |
Loose Or Intermittent Connection | 4 |
Rod | 4 |
Material Fragmentation | 4 |
Separation Failure | 4 |
Inadequacy Of Device Shape And/or Size | 3 |
Device Or Device Fragments Location Unknown | 3 |
Detachment Of Device Or Device Component | 3 |
Failure To Align | 3 |
Mechanical Problem | 3 |
Component Missing | 3 |
Difficult To Open Or Close | 2 |
Metal Shedding Debris | 2 |
Melted | 2 |
Defective Component | 2 |
Driver | 2 |
Contamination During Use | 2 |
Split | 2 |
Flaked | 2 |
Difficult To Insert | 2 |
Dull, Blunt | 2 |
Sticking | 2 |
Peeled / Delaminated | 2 |
Device Misassembled During Manufacturing / Shipping | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Plate | 2 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
Device Issue | 1 |
Locking Mechanism | 1 |
Device Handling Problem | 1 |
Device Subassembly | 1 |
Accessory Incompatible | 1 |
Difficult Or Delayed Activation | 1 |
Malposition Of Device | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Device Markings / Labelling Problem | 1 |
Positioning Problem | 1 |
Material Rupture | 1 |
Connector | 1 |
Disconnection | 1 |
Entrapment Of Device | 1 |
Material Erosion | 1 |
Device Expiration Issue | 1 |
No Device Output | 1 |
Difficult To Position | 1 |
Shelf Life Exceeded | 1 |
Packaging Problem | 1 |
Migration | 1 |
Solder Joint Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Particulates | 1 |
Retraction Problem | 1 |
Degraded | 1 |
Mixer | 1 |
Device Dislodged Or Dislocated | 1 |
Material Split, Cut Or Torn | 1 |
Delivered As Unsterile Product | 1 |
Residue After Decontamination | 1 |
Wire | 1 |
| Total Device Problems | 735 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DePuy Orthopaedics, Inc. | II | Oct-09-2014 |
| 2 | Exactech, Inc. | II | Aug-11-2017 |
| 3 | Medtronic Sofamor Danek USA Inc | II | Feb-09-2018 |
| 4 | Smith & Nephew, Inc. | II | Jan-24-2018 |
| 5 | Trilliant Surgical Ltd. | II | Jul-02-2018 |