SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ5-6/8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71436137 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/08/2020 |
Event Type
malfunction
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Event Description
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It was reported that the insert trial was found to be broken.As this was noticed upon inspection, no patient was involved.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the trial a deep gouges and burrs in the plastic.The device shows significant signs of wear/usage.The device was manufactured in 2018.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.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.
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