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Model Number BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
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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On 02/08/2024, it was reported by an arthrex subsidiary employee via email that an ar-2323bcc suture anchor peek eyelet was damaged when threading the eyelet.No case involvement or patient harm.Used a new product and the case is completed.No patient harms.Additional information provided 2/21/2024: when the suture was threaded through the eyelet was when the ar-2323bcc suture anchor peek eyelet was damaged.The instrument was used to make a bone socket.The bone quality of the patient was normal.
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Search Alerts/Recalls
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