SMITH & NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74018901 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The rubber on the device is fractured with gouges and burrs, rendering the device inoperable. the device was manufactured in 2008 and shows signs of extensive use.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. we consider this investigation closed.
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Event Description
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It was reported that the journey tibial impl impactor was found to be heavily gouged during a routine efip inspection.There was no case involved.
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The plastic bumper on the device is fractured with gouges and burrs, rendering the device inoperable.The device was manufactured in 2008 and shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.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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