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Catalog Number 7205335 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a hip arthroscopy, the full radius blade had wear and remnants of foreign bodies of metal from the blade, and small debris in the joint.The surgeon locked at the tip of the blade and noticed wear on the inside of the blade.The procedure was finished with the same device.No delay or further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The inner shaft is damaged at the flexible portion.The distal tip shows degradation and the inner shaft was unable to be removed from the outer shaft without further damage.There is biological debris on the returned device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The instructions for use, dyonics disposable endoscop blades document, was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.The root cause was associated with unintended use of the device.Factor that could have contributed to the reported event is insufficient irrigation during use.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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