SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 4MM; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Catalog Number 71434304 |
Device Problem
Defective Component (2292)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/19/2019 |
Event Type
malfunction
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Event Description
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It was reported that the surgeon reported issues with coupler trial.A s&n backup was available to complete the procedure without delay.There was no injury to the patient.
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Manufacturer Narrative
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The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The locking screw was missing, rendering the device inoperable.The device was manufactured in 2014 and exhibits signs of extensive wear/ usage.A review of complaint history did not reveal additional complaints for the listed batch.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 product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 is 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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