(b)(4).Manufacturing site evaluation: several areas with missing diamonds are visible.A safety team was convened.It can be assumed that the failure was caused by a change of the manufacturing process.Since this change, the burrs were no longer brushed after the coating to remove the loose diamonds.Due to this reason, the risk occur that the diamonds can detach of the burr.A patient hazard cannot be assessed at this stage, thus the following task were initiated: creation of a risk assessment.Statement of the manufacturer.Blocking of the warehouse.Clinical evaluation.Forward a list of requirements to manufacturer.Detection of remaining nickel on loosened diamond.Follow-up safety team.The product does not require batch management; a review of the device quality and manufacturing history records is not possible.Based on the information available as well as a result of our investigation the root cause of the failure is most probably a manufacturing error.
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