SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 74012417 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
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, during a tka surgery, when removing one (1) journey dcf ap fem cut blk 7, a small ball bearing fell out of the sliding mechanism of the block.The bearing was retrieved.The block appears normal to the naked eye, but the pegs on the back of the block move slightly even when screw was completely locked.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the ball bearing is missing from the device.This piece was not returned.The device shows signs of extensive wear and use.At this time, we have no evidence to conclude that the product failed to meet any 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 potential factors that could contribute to 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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