SMITH & NEPHEW, INC. JOURNEY ART ISRT ASSM TOOL; PROSTHESIS,KNEE,FEMOROTIBIAL,SEMICONSTR,CEMENT,MET/POLY
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Model Number 74018911 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2020 |
Event Type
malfunction
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Event Description
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It was reported that in a total knee arthroplasty it was noticed that the journey art insert assm tool had the broken tip.No delay or injury to the patient reported.Smith and nephew back up device available.
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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 confirmed the stated failure mode.The tip of the device is fractured.The fractured pieces were not returned.The device was manufactured in 2007 and shows signs of extensive use.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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