ARTHREX, INC. SELF BUNCHING KL 1.8 FIBERTAK, HIP; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number SELF BUNCHING KL 1.8 FIBERTAK, HIP |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/20/2021 |
Event Type
malfunction
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Event Description
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On (b)(6) 2021 it was reported by a sales representative via sems that an ar-3636h broke during a hip arthroscopy.This was discovered after the case when most of the implant was still on the inserter.After an x-ray it was confirmed the tip was still implanted in the patients bone.It was determined the fixation was successful and the patient is fine to date.
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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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Manufacturer Narrative
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Complaint confirmed, the tip of the inserter was found to be broken.Fragments were not returned.The cause of the event is undetermined, however likely causes include prying/leveraging the device during use.
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Search Alerts/Recalls
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