The reported event could not be confirmed because the information provided was not sufficient.In order to obtain more details about the reported event and determine a complaint root cause, the ¿infection complaints ¿ checklist customer¿ (cmfqf 13-003) was forwarded to the sales rep.However, it was stated that no further information can be provided.For infection complaints expanded investigations are performed at the manufacturing site, stryker orthopaedics, in limerick (ireland) to assure that neither the complained device nor all related manufacturing process steps have caused or contributed to the reported event.Furthermore, it is evaluated if the risk assumptions in the related fmea are in correspondence with the reported event.In this case no lot number was provided.Therefore, it is considered to be appropriate to reference a checklist that was completed for a former infection complaint in which also no lot number was reported and the same catalog number was involved (pi 2081849).Within that expanded investigation no discrepancies were documented within the corresponding ¿infection complaints - checklist investigator¿ (cmfqf 13-002).Summarizing all obtained information, the complaint root cause could not be determined because the information provided was not sufficient.Based on the investigation including a statistical analysis, as well as, based on the results of the expanded investigation at the manufacturing site there is no indication that the product is not working as intended or any systematic design, material, or manufacturing related issue exists.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.
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