SMITH & NEPHEW, INC. GII UNIVERSAL EXTRACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440366 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the gii universal extractor confirms there is a fracture at the capture head portion of the device.This instrument exhibits signs of extreme use and wear.A review of complaint history did not reveal additional complaints for the listed batch.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 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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Event Description
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It was reported that, the weld of a gii universal extractor was splitting at the capture head.As this was noticed upon cleaning and sterilization activities, there was not patient involvement.
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