SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74012414 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/08/2020 |
Event Type
malfunction
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Event Description
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It was reported that the small pin broke off and the block was not staying together, so it can not use.There isn´t a patient involved in the case.
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Manufacturer Narrative
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Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned cutting block confirms one of the pins on the device broke off.The broken piece was not returned.There are several burrs and gouges in the metal as well.This device was manufactured in 2015.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.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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