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
Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/28/2020 |
Event Type
malfunction
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Event Description
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It was reported that during inspection, it was noticed that the holes on the distal cutting block had burrs and pins could not go thru easily.No patient involved.
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2011 and shows signs of extensive use.A functional evaluation of the returned device confirms the stated failure mode.The device has burrs, rendering the device inoperable.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.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.
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