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Model Number CORKSCREW FT, BC, SUTURETAPE, 4.75MM |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/13/2024 |
Event Type
malfunction
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Event Description
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On 3/19/2024, it was reported by a sales representative via email that (3) ar-1927bct-475 biocomposite corkscrew ft anchors broke during implantation.The broken fragments were removed, and the case was completed using swivelocks.This was discovered during an rcr procedure on (b)(6) 2024.Additional information requested.
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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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Search Alerts/Recalls
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