The subject product was not available for evaluation.
This is the first reported complaint for the subject lot of (b)(4) units manufactured in september, 2016.
Based on the information currently available, no conclusion can be drawn.
As reported there was device to device interface and the forces applied may have contributed to the problem experienced.
If additional information is provided, a supplemental mdr will be submitted.
This report represents the ventrio st (device #1).
An additional mdr will be submitted to represent the enhanced sorbafix device used (device #2).
Of 3500a report ((b)(4)) provided to davol by the user facility.
The information provided by bard represents all of the known information at this time.
Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Device implanted.
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It was reported that during a laparoscopic repair of a recurrent incarcerated incisional hernia using a bard/davol ventrio st mesh (device #1) and the bard/davol sorbafix fixation device (device #2), the fixation device deployed two fasteners at once and then would not deploy at all.
A fastener was fired through the entire mesh and the head broke off of the fastener and the fastener fell into the abdomen.
All loose pieces were retrieved.
Another sorbafix was used to complete the case.
The surgeon is an experienced user of the device.
There was no delay to the procedure and no patient injury was reported.
As the problem reported resulted in a hole in the ventrio st mesh material there was some compromise to the implants adhesion barrier.
Although this is unlikely to result in patient harm, there is a potential incremental risk to the patient and an mdr is being filed to report the malfunction.
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