It was reported that, during surgery, the r3 offset impactor tip broke while implanting a cup.All the pieces were accounted for before continuing the case.Procedure continued with a backup device without any delay.The patient was not harmed beyond what has been described here.
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, per complaint details, the impactor tip broke while implanting a cup; however, ¿all the pieces were accounted for¿ before continuing the case with a backup device.There was no delay or injury reported.Based on the information provided, the root cause of the reported event could not be definitively concluded.No further patient impact would be anticipated as the procedure was reportedly continued with the use of a backup device.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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