(b)(4).Report source: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified one part with the nitinol kite closed.Second part was returned where one has a broken kite and bio-material blocking the kite.The other one has bio-material blocking the kite from deploying.The ez pass handles moves the nitinol as intended except for the one that is broken.The one with the bio-material moves the nitinol wire but does not deploy it out of the tip.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to off-label use as this device was being used in an open bankart procedure.This instrument is intended to be used arthroscopically.It is unknown which instrument was broken if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.A summary of the investigation has been sent to the complainant.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03309.
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It was reported that the suture passer disp.Instruments did not open up the loop for catching the suture during the open bankart procedure.First time the loop open properly, but with the second suture the loop stayed close.The surgeon tried 2 extra instruments with the same result.On device evaluation, fracture was noted on the kite wire.No additional patient consequences are known.
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