It was reported that during a posterior cruciate ligament reconstruction procedure, the 9-10mm plug bone tunnel device fractured when it was inserted into the 9mm tunnel, the distal fragment remained inside the tunnel.Another incision had to be made to insert a pin through the tunnel and remove fragment completely.The procedure was successfully completed using a back-up device.There a surgical delay less than 30 minutes and no further complications were reported.
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H10: h3, h6: 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 could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Corrected data: h6: health effect - clinical code.
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