SMITH & NEPHEW, INC. NS VIS ADPT GUIDE JII TIB; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Model Number V0200111 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during tka surgery, a ns vis adpt guide jii tib tibial adaptive guide was noticed to have a negative slope on it.The procedure was concluded using a smith and nephew backup device, and no significant delay in surgery occurred due to this event.Neither patient injury nor other complications were reported.
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Manufacturer Narrative
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The associated device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of attempted use.The engineering evaluation confirmed the stated failure mode.The evaluation determined that there was under segmentation on the anterior medial tibia and over segmentation on the proximal tibia which may have caused the block to fit incorrectly.The engineer and segmenter were retrained by the segmentation subject matter expert.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable causes for this event is likely a design error.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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