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
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/10/2020 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, while outside the patient, the spring lever on the item snapped.Procedure was concluded with a backup device from smith and nephew.No delay and no injury reported.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection confirmed the spring is broken off the journey art isrt assm tool and has not been returned.The device shows significant signs of wear/usage.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 products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
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