SMITH & NEPHEW, INC. GII MIS DCF DISTAL CUT BLK; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71441147 |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/06/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during tka surgery, the pin became stuck in the hole of the genesis ii mis dcf distal cutting block.The procedure was finished using the same device, with no surgical delay and no injury to the patient.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The cutting block has several burrs and gouges in the different cutting slots.There is also a piece of a pin seized inside the cutting block.The other piece of the pin was not returned with the device.This device was manufactured in 2014.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 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 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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