It was reported that during tka surgery, upon opening implant box, the journey ii cr insert xlpe right size 1-2 9mm fell from the box because the sterile wrap was undone.An equivalent implant was available to be used.Surgery was not significantly delayed.The patient outcome is unknown.
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H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was returned without its packaging.A review of the provided pictures appeared to show the device in its opened original box with the device not sealed in the sterile pouch.The pouch appeared to have a breached seal.The device shows no sign of use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documentation revealed this failure mode was previously identified.Some potential probable causes for this event could include improper storage or rough handling.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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