| Device Type ID | 4484 |
| Device Name | Bit, Drill |
| 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 | HTW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4484 |
| Device | Bit, Drill |
| Product Code | HTW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RENOVO LIFE LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 1833 |
Fracture | 221 |
Bent | 219 |
Material Fragmentation | 215 |
Dull, Blunt | 165 |
Material Twisted / Bent | 122 |
Device Operates Differently Than Expected | 89 |
Appropriate Term/Code Not Available | 60 |
Corroded | 40 |
Failure To Cut | 32 |
Device-Device Incompatibility | 31 |
Failure To Align | 30 |
Insufficient Information | 28 |
Naturally Worn | 20 |
Crack | 20 |
Device Markings / Labelling Problem | 18 |
Mechanical Jam | 18 |
Use Of Device Problem | 18 |
Mechanical Problem | 17 |
Component Missing | 15 |
Delivered As Unsterile Product | 15 |
Material Deformation | 13 |
Tip | 12 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Packaging Problem | 11 |
Entrapment Of Device | 11 |
Separation Failure | 10 |
Incorrect Measurement | 9 |
Difficult To Remove | 9 |
Device Handling Problem | 8 |
Fitting Problem | 6 |
Defective Device | 6 |
Manufacturing, Packaging Or Shipping Problem | 5 |
Connection Problem | 5 |
Residue After Decontamination | 4 |
Loss Of Or Failure To Bond | 4 |
Metal Shedding Debris | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Material Integrity Problem | 4 |
Loose Or Intermittent Connection | 4 |
Temperature Problem | 4 |
Detachment Of Device Or Device Component | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Device Issue | 4 |
Device Packaging Compromised | 3 |
Detachment Of Device Component | 3 |
Material Erosion | 3 |
Mechanics Altered | 3 |
Pin | 3 |
Unraveled Material | 3 |
Difficult Or Delayed Positioning | 2 |
Device Difficult To Maintain | 2 |
Screw | 2 |
Degraded | 2 |
Deformation Due To Compressive Stress | 2 |
Product Quality Problem | 2 |
Device Inoperable | 2 |
Device Operational Issue | 2 |
Difficult To Insert | 2 |
Overheating Of Device | 2 |
Sticking | 2 |
Positioning Failure | 2 |
Patient Device Interaction Problem | 2 |
Unsealed Device Packaging | 1 |
Off-Label Use | 1 |
Incomplete Or Missing Packaging | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Unintended Collision | 1 |
Device Contamination With Biological Material | 1 |
Difficult To Position | 1 |
Cut In Material | 1 |
Device Or Device Fragments Location Unknown | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Kinked | 1 |
Unable To Obtain Readings | 1 |
Difficult To Advance | 1 |
Component Falling | 1 |
Material Distortion | 1 |
Human-Device Interface Problem | 1 |
Patient-Device Incompatibility | 1 |
Operating System Becomes Nonfunctional | 1 |
Unstable | 1 |
Vibration | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Contamination With Body Fluid | 1 |
Failure To Capture | 1 |
Misconnection | 1 |
Battery Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
Circuit Breaker | 1 |
No Apparent Adverse Event | 1 |
Disassembly | 1 |
Smoking | 1 |
Material Frayed | 1 |
Misassembled | 1 |
Shaft | 1 |
Coiled | 1 |
| Total Device Problems | 3460 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | May-26-2016 |
| 2 | Cayenne Medical Inc. | II | Jul-28-2018 |
| 3 | MicroAire Surgical Instruments, LLC | II | Jan-26-2018 |
| 4 | Synthes (USA) Products LLC | II | May-23-2016 |
| 5 | Synthes, Inc. | II | Jun-04-2015 |
| 6 | The Anspach Effort, Inc. | II | Jan-11-2014 |
| 7 | Tornier, Inc | II | May-09-2018 |
| 8 | Trilliant Surgical Ltd. | II | Aug-24-2015 |