H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tips of the device are bent, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that no relevant clinical information has been provided; therefore, a thorough medical investigation could not be rendered nor could a clinical root cause of the reported breakage be determined.It has not been confirmed whether the 4 rdce frcps w/ pts brds points were retained/removed from inside of the patient.If any of the 4 rdce frcps w/ pts brds points were retained, they are comprised of the non-implantable material din 1.4021.Therefore, we cannot rule out the possibility of local skin irritation, micro-motion and or migration of the possible retained pieces.According to the report, there was a delay of 30 minutes or less and the procedure was finished using a smith & nephew back up.Since there was no patient harm reported, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint would be re-assessed.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
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