| Device Type ID | 4499 |
| Device Name | Driver, Prosthesis |
| 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 | HWR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4499 |
| Device | Driver, Prosthesis |
| Product Code | HWR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 1178 |
Material Deformation | 345 |
Fracture | 108 |
Appropriate Term/Code Not Available | 92 |
Crack | 77 |
Device Slipped | 72 |
Naturally Worn | 38 |
Component Missing | 24 |
Device-Device Incompatibility | 23 |
Material Twisted / Bent | 20 |
Bent | 18 |
Connection Problem | 14 |
Mechanical Jam | 11 |
Insufficient Information | 11 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Torn Material | 9 |
Material Fragmentation | 9 |
Mechanical Problem | 7 |
Material Split, Cut Or Torn | 6 |
Difficult To Insert | 5 |
Material Torqued | 5 |
Device Issue | 4 |
Use Of Device Problem | 4 |
Difficult To Remove | 4 |
Device Operates Differently Than Expected | 3 |
Disassembly | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Entrapment Of Device | 3 |
Dull, Blunt | 3 |
Failure To Disconnect | 3 |
Output Problem | 3 |
Defective Device | 2 |
Separation Problem | 2 |
Scratched Material | 2 |
Loose Or Intermittent Connection | 2 |
Misconnection | 2 |
Defective Component | 1 |
Lock | 1 |
Corroded | 1 |
Migration Or Expulsion Of Device | 1 |
Tip | 1 |
Delivered As Unsterile Product | 1 |
Output Above Specifications | 1 |
Disconnection | 1 |
Material Distortion | 1 |
Calibration Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Packaging Problem | 1 |
Failure To Align | 1 |
Detachment Of Device Component | 1 |
Sticking | 1 |
Fitting Problem | 1 |
Device Subassembly | 1 |
Physical Resistance / Sticking | 1 |
Separation Failure | 1 |
Incomplete Or Missing Packaging | 1 |
| Total Device Problems | 2145 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet U.K., Ltd. | II | Feb-22-2017 |
| 2 | Smith & Nephew, Inc., Endoscopy Div. | II | Jan-29-2016 |