SMITH & NEPHEW, INC. GII HOUSING REAMER DOME; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Catalog Number 71440142 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2020 |
Event Type
malfunction
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Event Description
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It was reported that the reamers were found dull, during surgery.There was no delay in the case.The case was finished with the same device.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection was conducted and confirmed the housing reamer dome is dull.The device was manufactured in 2020.This device shows 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 a manufacturing abnormality 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.
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