It was reported that during a rotator cuff repair, when releasing the suture from the suture forceps, a small part of the jaw in the first pass mini broke off.The part broke outside the patient and nothing fell nor remained into the patient's anatomy.The procedure was completed with a smith and nephew back up device.There was a delay less than 30 minutes and no further complications were reported.
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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.A review of device records showed 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.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.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.
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