| Device Type ID | 4505 |
| Device Name | Wrench |
| 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 | HXC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4505 |
| Device | Wrench |
| Product Code | HXC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GAUTHIER BIOMEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 103 |
Appropriate Term/Code Not Available | 48 |
Mechanical Problem | 25 |
Device Operates Differently Than Expected | 24 |
Fracture | 22 |
Mechanical Jam | 17 |
Bent | 14 |
Component Missing | 13 |
Crack | 12 |
Disassembly | 10 |
Output Above Specifications | 8 |
Naturally Worn | 8 |
Output Problem | 7 |
Calibration Problem | 6 |
Material Torqued | 5 |
Material Deformation | 5 |
Material Twisted / Bent | 5 |
Device Inoperable | 5 |
Difficult To Remove | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Device-Device Incompatibility | 4 |
Loose Or Intermittent Connection | 4 |
Material Fragmentation | 3 |
Device Issue | 2 |
Component Or Accessory Incompatibility | 2 |
Failure To Disconnect | 2 |
Insufficient Information | 2 |
Output Below Specifications | 2 |
Connection Problem | 2 |
Difficult Or Delayed Separation | 1 |
Device Operational Issue | 1 |
Material Discolored | 1 |
Misconnection | 1 |
Defective Device | 1 |
Mechanics Altered | 1 |
Positioning Problem | 1 |
Scratched Material | 1 |
Dull, Blunt | 1 |
Entrapment Of Device | 1 |
Misassembly By Users | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Sticking | 1 |
Fitting Problem | 1 |
Unintended Movement | 1 |
| Total Device Problems | 383 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap, Inc. | II | Aug-03-2015 |
| 2 | Biomet Spine, LLC | II | Apr-20-2015 |
| 3 | Bradshaw Medical Inc. | II | May-10-2016 |
| 4 | Orthofix, Inc | II | Feb-11-2016 |