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Model Number BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/14/2024 |
Event Type
malfunction
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Event Description
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On 03/26/2024, it was reported by an arthrex subsidiary employee via email that an ar-2324bcct biocomposite swivelock anchor broke inside the patient.All the broken fragments were removed, and the case was completed using a new ar-2324bcct biocomposite swivelock.This was discovered during an rcr procedure on (b)(6) 2024.
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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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