It was reported that, during a knee arthroscopy, it was noted that the acufex device that was being used was broken after removing it from the patient's knee.The doctor was concerned it could have left a broken piece of the instrument inside the patient's knee, therefore, x-ray was done and confirmed there was no metal/ broken piece of the instrument in the patient's knee.The broken instrument was examined at the end of the case, the doctor did not think there were any pieces of instrument that broke off inside the patient.It is unknown if there was a back-up device available or if there was a delay.No further complications were reported.
|
A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, instruction for use review, risk management review, could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A clinical review states that x-rays confirmed there was no metal/ broken piece of the instrument in the patient's knee.Although requested, no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time to determine the clinical root cause of the reported events.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.Corrected information.H6: health effect - clinical code and health effect - impact code.
|