SMITH & NEPHEW, INC. GII MIS DCF DISTAL CUT BLK; PROSTHESIS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CMNTD,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 07/13/2020 |
Event Type
malfunction
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Event Description
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It was reported that the trocar pin got jammed in the alignment hole.It is unknown if there was a delay.No patient injuries reported.An s&n backup was not required as the procedure was finished with the same device.
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Manufacturer Narrative
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The devices, uses in treatment, were returned for evaluation.A visual inspection confirmed the pin is stuck in the cutting block.The devices show significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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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