One ustar ii 25 mm segment was reported as broken and the device was returned for evaluation.The manufacturing data of this device was verified and met the design specification.The original design met design, testing and safety requirements and received 510(k) clearance.However, the fracture condition of the returned device was inconsistent with fatigue testing results which follow by norms.Based on one failure, it was determined to increase the design fracture of safety to a higher level on the 25 mm segment.The modified design had increased the factor of safety to account for possible conditions the parts might see that are outside the norms of standard testing protocols.
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Additional evaluation of the complained device,devices in the same lot, devices of the same size and a different lot were evaluated via documentation review as well as biomechanical testing.The manufacturing data of this device were verified and met the design specification.Observing the returned device,the fracture condition was inconsistent with fatigue testing results which follow by norms.According to above investigation, this device met design, testing and safety requirements, referring it was a single case caused by uncertain clinically factors.
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