Model Number BIO-COMP-SITE P-LCK 2.9X15.5MM |
Device Problem
Defective Device (2588)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/11/2023 |
Event Type
malfunction
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Event Description
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On 9/11/2023, it was reported by an arthrex subsidiary employee via email that an ar-1923bc biocomposite pushlock eyelet was found damaged after removing the anchor.This was discovered during a procedure on (b)(6) 2023.The case was completed using a product from another manufacturer.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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