Model Number BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/15/2023 |
Event Type
malfunction
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Event Description
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On 10/16/2023, it was reported by an arthrex subsidiary employee via email that an ar-2323bcc biocomposite swivelock c anchor pulled out.The case was completed using another ar-2323bcc biocomposite swivelock c from a different lot number.This was discovered during an rcr procedure on (b)(6) 2023.
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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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