Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection has revealed that cement was hardened inside the cement reservoir and there were some hardening liquid inside the pump.Cement was also found at the internal thread.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.Potential root cause can be that mixing bowl and cement reservoir might not have properly attached together during cement transfer and it may caused it to cement to leak.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, 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.
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