SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 36 +4; PROSTHESIS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER
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Model Number 71343600 |
Device Problem
Break (1069)
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Patient Problem
Failure of Implant (1924)
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Event Date 06/28/2021 |
Event Type
malfunction
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Event Description
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It was reported that after visual inspection of the device mi trial fem head 36 +4 it was confirmed that one of the tabs broke off the device, rendering it inoperable.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation a visual inspection of the returned device confirms two of the inner tabs broke off.The broken pieces were not returned with the device.This device shows signs of excessive wear/usage.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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