A cup introducer (90128257, s0703054), was received for investigation.It was reported that the device was found broken during a routine efip inspection.No case involved.Visual inspection noted that there were scratches across the device consistent with surgical use a functional evaluation was performed, which showed that the top of the device was broken off and the device will no longer be able to function.This does confirm the reported complaint a review of the complaint history for the cup introducer was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the cup introducer.This will continue to be monitored.As the supplier is no longer in business and that there is no traceability within sap, the manufacturing records for this device cannot be reviewed.However, all the released instruments involved would have met manufacturing specifications at the time of production.Based on the available information and the product evaluation the root cause has been determined as a fracture problem.
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