Event: trace of blood stains.When opening this box, there were two spots.As we could not tell if it was blood or rust, the hospital employee used hydrogen peroxide and then the surgeon said he did not consider that a sterile box anymore, so he suspended it.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary : the device associated with this report was not returned.A review of a provided photograph confirmed rust at the etch.The root cause is attributed to inappropriate cleaning counter to the recommendations in the instructions for use (ifu).Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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