SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 8; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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Model Number 74012418 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during inspection process it was found that the sealer over function screw has been dug out of the journey dcf ap fem cut blk 8.As this was notice in a field inspection, not patient was involved.
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Manufacturer Narrative
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The device, intended for use in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.
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Manufacturer Narrative
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H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of extensive use and discoloration.A functional evaluation of the returned device does not confirm the stated failure mode.The device functions as necessary.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 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.
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