As reported per the medwatch #(b)(4): "patient was having a surgical procedure ¿laparoscopic umbilical hernia repair with mesh¿.During the procedure, the sorbafix fired correctly the first few times and then made a loud crack noise.The surgeon stopped using piece of equipment and removed it for evaluation.Upon inspection, it was noted to have a crack.Removed from the sterile field.Md aware.New sorbafix was opened and finished procedure.No harm noted.Fda safety report id # (b)(4).".
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As reported, the bard/davol sorbafix enhanced fixation device fired correctly and then cracked.There was no reported patient injury.The information provided is limited to the maude event report.Contact information was not provided, therefore, we are unable to request additional information.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of 770 units released for distribution in (b)(6),2021.The precautions section of the instructions-for-use (ifu) supplied with the device states "care should be taken not to use excessive counterpressure as this may damage the distal tip of the device as well as the mesh and/or tissue¿.
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