It was reported that, during tka surgery, a gii ps high flex impctr hd 3-8 pieces chipped on impaction.All pieces were retrieved, no piece fell into the patient.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.
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H3, h6: the associated device was returned and evaluated.Upon visual inspection, it is confirmed that pieces of the device have chipped off from the device.None of the chipped parts were returned with the product.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that no relevant supporting clinical documentation has been provided.Therefore, a thorough medical investigation could not be rendered, nor could a definitive root cause of the reported failure be determined.Based on the information provided, all the chipped pieces were retrieved and none of the chipped pieces fell into the patient.According to the report, the surgeon was able to complete the procedure without delay using a s&n back-up device.Since there was no harm alleged to this patient, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.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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