This is the report of the first incident of two similar incidents reported by the initial reporter on 6/25/2019.Identifying information of the part, such as the part number and lot number of the device was not reported to paragon 28.Devices are not expected to be returned for the manufacturer review/investigation.Case information including the facility and surgery date was not provided by the initial reporter.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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It was reported that the patient underwent a surgical procedure that utilized a phantom 4-hole intramedullary nail.After 10 weeks post-operatively, the nail was found bent and broken at the distal cuneiform hole, and it was reported that the patient displayed a non-union.No revision surgery was reported.
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