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This device is manufactured by DEPUY SYNTHES POWER TOOLS, DEPUY SYNTHES PRODUCTS, THE ANSPACH EFFORT.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Premature Separation | 1 | Device |
| 2024 | Mechanical Jam | 1 | Device |
| 2023 | Excessive Heating | 1 | Device |
| 2023 | Difficult or Delayed Separation | 2 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Vibration | 1 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | Excessive Heating | 4 | Device |
| 2022 | Device-Device Incompatibility | 1 | Device |
| 2022 | Detachment of Device or Device Component | 3 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Vibration | 23 | Device |
| 2019 | Overheating of Device | 16 | Device |
| 2019 | Material Separation | 1 | Device |
| 2019 | Material Fragmentation | 1 | Device |
| 2019 | Fluid/Blood Leak | 1 | Device |
| 2019 | Detachment of Device or Device Component | 18 | Device |
| 2018 | Vibration | 35 | Device |
| 2018 | Smoking | 2 | Device |
| 2018 | Overheating of Device | 33 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | Metal Shedding Debris | 2 | Device |
| 2018 | Material Twisted/Bent | 1 | Device |
| 2018 | Fluid/Blood Leak | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Inoperable | 2 | Device |
| 2018 | Detachment of Device or Device Component | 23 | Device |
| 2018 | Detachment Of Device Component | 13 | Device |
| 2018 | Break | 1 | Device |
| 2017 | Vibration | 24 | Device |
| 2017 | Overheating of Device | 35 | Device |
| 2017 | Naturally Worn | 1 | Device |
| 2017 | Material Separation | 1 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Difficult To Position | 1 | Device |
| 2017 | Device Operational Issue | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 2 | Device |
| 2017 | Detachment of Device or Device Component | 1 | Device |
| 2017 | Detachment Of Device Component | 22 | Device |
| 2016 | Temperature Problem | 4 | Device |
| 2016 | Overheating of Device | 3 | Device |
| 2016 | Naturally Worn | 2 | Device |
| 2016 | Material Separation | 1 | Device |
| 2016 | Material Disintegration | 1 | Device |
| 2016 | Incorrect Or Inadequate Test Results | 1 | Device |
| 2016 | Difficult to Insert | 2 | Device |
| 2016 | Device Inoperable | 2 | Device |
| 2016 | Detachment Of Device Component | 3 | Device |
| 2016 | Component Missing | 2 | Device |
| 2016 | Break | 4 | Device |
| 2014 | Temperature Problem | 2 | Device |
| 2014 | Device Operates Differently Than Expected | 2 | Device |
| 2013 | Melted | 1 | Device |
| 2011 | Difficult to Insert | 1 | Device |