SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 6; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENT, MET/POLY
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Model Number 74012416 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/09/2020 |
Event Type
malfunction
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Event Description
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It was reported that after tka surgery, was identified that the mechanism in the back of the journey dcf ap femoral cutting block 6 fell apart.There was no patient involved when the issue was noticed.
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Manufacturer Narrative
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The device, used treatment, was returned for evaluation.A visual inspection of the returned cutting block confirms the spiked cross bar, cross bar screw and indicator cam pin came apart from the device.All pieces were not returned for evaluation.The device was manufactured in 2015.The device exhibits signs of significant wear and 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.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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