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Model Number FIBERTAK |
Device Problems
Break (1069); Material Frayed (1262)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that during a procedure, qty.2 of the ar-3638 anchors failed at the same tape/#2 suture junction upon shuttling through the knotless mechanism.The ar-3628 was frayed and broke at that junction in both anchors causing the anchor to be unusable.The case was completed by using a third ar-3638.
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Search Alerts/Recalls
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