(b)(4).As the product has not been received, the investigation was limited to the information provided.A review of the manufacturing history records was not performed as lot number is not available.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.The reported event states trial bearing fracture.The details of the reported event do not allege that there was any patient harm or delay to surgery.Therefore, the severity is considered s-1 (negligible) as per definitions within the severity table in the rmr, which is in line with the risk file.The outcome of this complaint is considered to be within the severity of the rmr.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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