It was reported that, during tka, a modular legion femoral impactor fractured at the junction between the peg that locks into the modular handle and the base of the impactor.No debris entered the patient.The wound was vigorously irrigated to ensure no debris was mistakenly left inside the patient.Surgery was resumed, after a non-significant delay, with a back-up device.The patient was not injured as a consequence of this problem.
|
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the modular impactor shaft and dowel pin broke off the device.These pieces were not returned.The device shows signs of significant wear and use.The reported event could be confirmed.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.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 can no 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 likely potential factors that could contribute to 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.
|