SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,
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Catalog Number 71440145 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/14/2020 |
Event Type
malfunction
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Event Description
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It was reported that during inspection was found that the gii p/s cons housing ream dome is dull.There was no case involved.
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Manufacturer Narrative
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Find additional information received for this case in sections: d4 (lot number and expiration date) and h4.
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Manufacturer Narrative
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Results of investigation: the device, intended for use in treatment, was returned for evaluation.A visual inspection was conducted and confirmed the housing reamer dome is dull.The device was manufactured in 2012.This device shows signs of extreme 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 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.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.
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