Correction: please refer to h6 results code.The reported event could be confirmed, although the device was not returned but a couple of x-ray were shared which confirms the reported failure mode.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.A formal medical opinion was sought from an independent medical professional based on the x-rays provided, but with the limited amount of information it was not possible to determine the exact cause.He opined that looking at the provided x-rays, signs of a starting/ongoing hypertrophic non-union could be observed.These fractures are known for their instability and most often of a lack of compression at the fracture site, after fixation, which causes movement at the fracture site.This movement will prevent the bone from healing and cause movement in the interface between the nail and the screw continuously.The movement results in friction/ fatigue/ breakage etc.Looking at the event, it seems that the fracture did not heal after the initial surgery.The attached x-rays show non-union.The gamma-nail is not intended to weight bear for such a long time, which is stated in our labelling documents.More information, patient details as well as the affected device must be available in order to determine the exact root cause of the issue.However, most probably the breakage occurred due to overloading of the nail as a result of non-union.The non-union is most probably due to the complex nature of the fracture and due to an inadequate reduction of the fracture.If the device is returned or any additional information is provided, the investigation will be reassessed.
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