It was reported that during the arthroscopy, the firstpass suture passer, could catched the suture and the needle of the device found to be broken.The procedure was completed with a smith and nephew back-up device.No patient injury, delay or other complications were reported.
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Internal complaint reference: (b)(4).The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.The needle does not have any visible damage or issues.A functional evaluation revealed the needle will deploy when trigger is initiated, the suture capture functioned and passed sutures as intended.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 concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
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