SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 5; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74012415 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/27/2021 |
Event Type
malfunction
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Event Description
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It was reported that, the moving parts of the journey dcf ap fem cut blk 5 are stuck/frozen.No further details were provided.No case reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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H6: the device, intended for use in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.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.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.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 has scratches and burrs.The device shows signs of extensive use.A functional evaluation of the returned device confirmed the stated failure mode.The knob and locking mechanism of the block is seized up.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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