International affiliate reports leakage of the confidence kit¿s pump.Cement application was not possible.A substitute confidence kit was used.There were no adverse consequences to the patient and no resulting delay.A review of the device history record could not be performed as the lot code is unknown.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.Without the return of the confidence kit, we are unable to confirm the reported issue or identify the root cause.As no systemic trends have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned.
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