SMITH & NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74018901 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that the edge of impacting end of a journey tibial impl impactor was hit and started a small crack.It could lead to metal shavings breaking off in a case.As this was noticed upon field inspection, there was no patient involvement.
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Manufacturer Narrative
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The associated device was returned and evaluated.A visual inspection of the returned journey tibial impl impactor confirms the bumper has multiple scratches, burrs and deep gouges in it.This device exhibits signs of significant wear/usage.A review of complaint history revealed similar events for the listed batch, this failure mode will be monitored for future complaints 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.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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 future complaints and investigate as necessary.
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