SMITH & NEPHEW, INC. BLADE 3.5 CURVED CONCAVE FULL RADIUS; SAW, POWERED, AND ACCESSORIES
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Catalog Number 7210980 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a knee arthroscopy two (2) blade concave full radius broke at the curve.Inside the patient, there was no debris in the knee.They were oscillating fine and the tip just stopped because the inner lumen was broken.The inner-lumen of the shavers broke at the bend of the shavers, the outer lumen were intact.No metal shavings in the knees.It is unknown if there was a back up device available or if there was a delay.No 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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H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 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.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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