| Device Type ID | 4696 |
| Device Name | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HWE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4696 |
| Device | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Product Code | HWE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Device Problems | |
|---|---|
Unintended System Motion | 2311 |
Fail-Safe Problem | 2078 |
Mechanical Jam | 1232 |
Noise, Audible | 1128 |
Device Inoperable | 1007 |
Device Operates Differently Than Expected | 941 |
Output Below Specifications | 852 |
Overheating Of Device | 729 |
Break | 616 |
Fracture | 274 |
Mechanical Problem | 240 |
Disassembly | 210 |
Device Remains Activated | 209 |
Unintended Power Up | 189 |
Detachment Of Device Or Device Component | 176 |
Vibration | 173 |
Leak / Splash | 157 |
Device Stops Intermittently | 150 |
Detachment Of Device Component | 134 |
Material Fragmentation | 124 |
Fluid Leak | 122 |
Metal Shedding Debris | 117 |
Appropriate Term/Code Not Available | 113 |
Battery Problem | 110 |
Sticking | 107 |
Difficult To Position | 105 |
Device Operational Issue | 98 |
Control Switches | 93 |
Unexpected Shutdown | 90 |
Intermittent Energy Output | 89 |
Failure To Power Up | 83 |
Loose Or Intermittent Connection | 61 |
Naturally Worn | 54 |
Motor | 53 |
Failure To Charge | 50 |
Battery | 48 |
Migration Or Expulsion Of Device | 47 |
Dull, Blunt | 46 |
Positioning Problem | 45 |
Component Missing | 45 |
Physical Resistance / Sticking | 44 |
Biocompatibility | 41 |
Device Disinfection Or Sterilization Issue | 40 |
Defective Component | 38 |
Temperature Problem | 34 |
Partial Blockage | 33 |
Smoking | 31 |
Difficult To Remove | 29 |
Material Deformation | 29 |
Loss Of Power | 29 |
Device-Device Incompatibility | 28 |
Device Slipped | 26 |
Crack | 25 |
Self-Activation Or Keying | 25 |
Connection Problem | 24 |
Switch, Push Button | 24 |
Material Disintegration | 22 |
Difficult To Insert | 21 |
Defective Device | 21 |
Unintended Movement | 20 |
Intermittent Loss Of Power | 20 |
Material Separation | 17 |
Fitting Problem | 17 |
Bent | 17 |
Power Problem | 17 |
Switches | 16 |
Air Leak | 16 |
Failure To Shut Off | 16 |
Bearings | 15 |
Insufficient Information | 14 |
Flaked | 14 |
Delivered As Unsterile Product | 11 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Handpiece | 11 |
Charging Problem | 11 |
Power Conditioning Problem | 10 |
Premature Discharge Of Battery | 10 |
Entrapment Of Device | 10 |
Device Subassembly | 10 |
Device Contamination With Chemical Or Other Material | 10 |
Fuse | 9 |
Coupler | 9 |
No Device Output | 9 |
Failure To Cut | 9 |
Pin | 9 |
Material Integrity Problem | 9 |
Melted | 8 |
Tip | 8 |
Controller | 8 |
No Fail-Safe Mechanism | 7 |
Disconnection | 7 |
Difficult To Open Or Close | 7 |
Device Displays Incorrect Message | 7 |
Corroded | 7 |
Physical Resistance | 7 |
Sparking | 7 |
Material Twisted / Bent | 6 |
Thermal Decomposition Of Device | 6 |
Locking Mechanism | 6 |
Housing | 5 |
| Total Device Problems | 15513 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 2 | Greatbatch Medical | II | Jun-01-2016 |
| 3 | Medtronic Sofamor Danek USA Inc | II | Jan-12-2015 |
| 4 | Smith & Nephew, Inc., Endoscopy Div. | II | Oct-22-2015 |
| 5 | Stryker Instruments Div. Of Stryker Corporation | II | Apr-27-2017 |
| 6 | Stryker Instruments Div. Of Stryker Corporation | II | Oct-18-2016 |
| 7 | Stryker Instruments Div. Of Stryker Corporation | III | May-07-2015 |
| 8 | Stryker Instruments Div. Of Stryker Corporation | II | Feb-09-2015 |
| 9 | Stryker Instruments Div. Of Stryker Corporation | II | Nov-05-2014 |
| 10 | Synthes (USA) Products LLC | II | Dec-01-2016 |
| 11 | Synthes (USA) Products LLC | II | Jul-12-2016 |
| 12 | Synthes, Inc. | II | Mar-23-2015 |
| 13 | The Anspach Effort, Inc. | II | Jan-11-2018 |
| 14 | The Anspach Effort, Inc. | I | Sep-27-2016 |
| 15 | The Anspach Effort, Inc. | II | Apr-30-2015 |
| 16 | Zimmer Biomet, Inc. | II | Sep-22-2017 |