SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER 5.5MM PLATINUM; SAW, POWERED, AND ACCESSORIES
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Model Number 72202530 |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that the top of the platinum full radius bonecutters were shedding bits of metal.Upon inspection, the top of the blades were rubbing against the outer sheath and causing their metal exterior coating to shed.No case reported; therefore, there was no patient involvement.No further information available.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H3, h6: samples from the reported lot were received for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection revealed that 27 individual devices were returned for evaluation.All of the devices were sealed in sterile packaging.No physical damage visible to the device.Five devices were chosen for physical evaluation.A functional evaluation was done on five devices per sample plan.The devices functioned as intended clockwise, counterclockwise, and while oscillating without signs of stress, shedding, or unintended noise.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
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