SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74012414 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/30/2021 |
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, after a tka surgery, a journey dcf ap fem cut blk 4 was noticed to be cracked.As this was noticed after procedure, the patient was no longer involved.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection was conducted and confirmed the middle of the device is cracked, rendering it inoperative.The device exhibits signs of significant wear and use.A review of complaint history revealed 7 similar events for the listed part number.No trend was found for this event.For the batch number, the review did reveal 1 similar event.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.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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.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.We consider this investigation closed.
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