H3: h6: the device used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.The device was manufactured in 2016.According to clinical/medical investigation, the plastic bottom of the impactor was ¿chunking off¿ during impaction; however, the baseplate was implanted successfully without delay, with the same device, and no foreign body was left in patient.Reportedly, there was ¿no impact to patient, patient outcome is fine¿.It was communicated that the requested medical documentation would not be provided for inclusion in the medical investigation.No patient injury or surgical delay is being alleged; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will not be issued for the device.
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