It was reported that the adapter device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the adapter would not secure/hold the actis broach securely.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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