The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.
The device history 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.
The instructions for use instructs user that: ¿before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.
¿ 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 risk management file review, possible cause of failure could be user related issue- the adjusting device pin was missing (loss during cleaning and checking set), without which adjusting device cannot be attached to target device for distal drilling.
If device is returned or any further information is provided, the investigation report will be reassessed.
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