SMITH & NEPHEW, INC. JOURNEY ART ISRT ASSM TOOL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74018911 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/05/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka, the surgeon had to squeeze the journey art isrt assm tool repeatedly, in order to lock the poly properly.S&n backup available.Surgery was not delayed.No harm to patient reported due this.
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Manufacturer Narrative
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The associated device, used 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 2013 and shows signs of extensive use.A functional evaluation confirmed that the device slider assembler mechanism is not functioning correctly.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 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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