It was reported that during a rotator cuff repair procedure, a piece of the upper jaw (the part that catches the suture/ tape) of the firstpass became loose and felt into the patient¿s joint.All pieces were removed from the patient with an artery (surgical instrument).The procedure was successfully completed with a delay of more than 30 min using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
H3,h6: the reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: inspect the instrument prior to use.Do not use the instrument if it appears defective, damaged, or otherwise compromised.Do not attempt to modify or repair the device.As with any surgical instrument, care should be taken to ensure that excessive force is not placed on the device.Excessive force can result in failure.Do not use this device as a lever for manipulating hard tissue or bone.Excessive force should not be applied to the device when manipulating soft tissue, bone, or hard objects.Misuse of this device may result in bent or broken distal tip or jaws.Tissue thickness may affect suture placement including stitch depth and needle entry point.When passing suture multiple times always check the tip of the device for damage or debris between passes.Clear any visible debris between passes.Discontinue use if the device becomes damaged between passes.Clinical/medical evaluation was completed and concluded that no patient injury or other complications were reported.Therefore, since no patient harm is being alleged, no further assessment is warranted at this time.Visual inspection shows the device was returned with an open top bracket; the steps of the trigger performed as intended; there were no manufacturing abnormalities found on the device.The firstpass suture passer is a single used device and could not be fully functional tested.An attempt was made to verify the basic functions.The needle could be triggered as specified; the device shows a detached suture capture part which was not returned with the device; no other malfunction could be identified.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness.(3) damage or debris in the device tip between passes.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
|