H3, h6: it was reported that the double offset adapter right will not stay locked in place and needs to be replaced.The failure was detected during set up or inspection and therefore, no patient was involved.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could not be confirmed.The device shows limited signs of use such as small dents and scratches, but no damage is observed on the connector site to the broach.Furthermore, the instrument was tested with gauge id-nr 0723.No deviation was detected.One additional complaint but with another reported failure mode was reported for the batch in question (a59149).A review of the production documentation for the batch in scope did not reveal any deviation from the standard operating procedure.To conclude, based on the performed investigations, the reported failure mode could not be confirmed.However, previous investigations demonstrated that under specific circumstances the double offset adapter 80/45 may disconnect from the rasp during backslapping.An optimized design of the device has been released in order to reduce the occurrence of this issue.This version of the device will be monitored for similar issues.The returned device will be discarded.This investigation is considered closed.
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