SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 7 LT; PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL
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Model Number 71433347 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/31/2020 |
Event Type
malfunction
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Event Description
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It was reported that the femoral trials were found cracked.This was discovered after the case.No patient was affected or delays were reported.
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Manufacturer Narrative
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The device, intended use in treatment, was returned for evaluation.A visual inspection of the returned trial confirms a crack in the metal of the device.This device was manufactured in 2011.This device exhibits signs of significant wear/usage.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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