Root cause: the root cause was determined to be an operator error at the manufacturing facility.Employees did not remove the sternum saw blade from the sealed plastic outer packaging.Employees were not adequately trained on the effect of this failure.Also, employees were not trained to clearly understand that failure to follow instructions and remove the outer packaging would cause a sterility hazard and pose a safety risk.Employees did not follow the work instructions, and work instructions were not adequate.Corrective action: photographic instructions of package removal will be provided.Additional instructions for package removal will be provided, including visual aid.Plant training will be conducted to provide employees with better understanding of the importance of ethylene oxide exposure to components.Investigation summary: an internal complaint ((b)(4)) was received indicating that a sternum saw blade contained within a convenience kit (part 89-7483, lot 53117579) contained a green sticker that said, "non-sterile." the product was discarded and not used on a patient.The sample was returned and received january 14, 2021.The product was left in a sealed plastic package that contains a green sticker indicating it is non-sterile.The work order was reviewed for discrepancies that may have contributed to the reported event.A discrepancy was identified.There is a line item for the affected component, raw material 5-51329, that states to remove from the package.A recall has been initiated.The official recall notice was sent to affected customers january 25, 2021.This medical device report is being submitted more than 30 days after the date deroyal became aware.The initial investigation into this incident did not reveal that the component packaging may have prevented ethylene oxide gas from sterilizing the device.It was not until quality assurance management reviewed the investigation that the product's sterility was identified as an issue.The relevant members of the complaint investigation team will be retrained on the medical device reporting requirements.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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