The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the labeling review, possible causes of failure could be user related (incorrect size selection, incorrect anatomical location, insufficient tightening of mating parts) and/or patient related (as patient is 80 years old, there are high chances of patient having osteoporotic bones, which may result into loosening of the device or premature loss of rigid fixation with the bone) if device is returned or any further information is provided, the investigation report will be reassessed.
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