| Device Type ID | 4485 |
| Device Name | Rongeur |
| 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 | HTX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4485 |
| Device | Rongeur |
| Product Code | HTX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 49 |
Fracture | 12 |
Material Fragmentation | 7 |
Material Deformation | 3 |
Insufficient Information | 3 |
Missing Value Reason | 3 |
Bent | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Component Missing | 2 |
Appropriate Term/Code Not Available | 2 |
Mechanical Problem | 2 |
Detachment Of Device Or Device Component | 1 |
Loose Or Intermittent Connection | 1 |
Detachment Of Device Component | 1 |
Material Torqued | 1 |
Failure To Cut | 1 |
Device Dislodged Or Dislocated | 1 |
Delivered As Unsterile Product | 1 |
Contamination / Decontamination Problem | 1 |
Cutter | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Corroded | 1 |
Material Discolored | 1 |
Device Inoperable | 1 |
Material Integrity Problem | 1 |
Device Fell | 1 |
| Total Device Problems | 104 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Exactech, Inc. | II | Jul-03-2017 |