Conclusion and justification status: the complaint states attune knee system broke during total knee arthroplasty, (b)(4) attune impaction handle (b)(4) attune femoral introducer.The exact failure mode of the devices was not mentioned.No products were returned hence the complaint cannot be confirmed.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Depuy still 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.
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