Examination of the returned devices confirms the reported event of trial breakage.The observed cracking/breakage is initiating around the metal insert of the trials.A (b)(4) meeting was held to discuss a product escalation out of australia concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.Although a definitive root cause is not known, a combination user technique, improper technique or misuse, and the use of contraindicated chemicals (non-compliant to cleaning guidelines), may lead to weakening of the material, as seen in the returned devices.Based on the performed investigation and (b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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