It was reported that during a shoulder arthroscopic rotator cuff repair, the grasper was broken, the jaws failed to close and lock.It was removed from the patient and inspected.The scrub tech tried to open and close the grasper and the top of the jaws and the articulation rod came apart.The procedure was completed with a s+n back-up device.There was no surgical delay and no further complications were reported.
|
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The grasper is fractured at the distal tip and the shaft is disconnected from the handle at the proximal end of the shaft.The set screw is disengaged.A functional evaluation could not be performed because the device is broken into several distinct pieces.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was 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.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
|