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Model Number SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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On 3/22/2024, it was reported by a sales representative via email that an ar-2923bc biocomposite pushlock anchor split in half during insertion.The broken fragments were removed, and another anchor was used to complete the case.This was discovered during a slap repair procedure on 3/21/2024.Additional information received on 3/27/2024: the case was not delayed and additional anesthesia was not needed.The patient suffered no negative effects.
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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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