SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 5; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 74012415 |
Device Problems
Break (1069); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka surgery, a pin hole on the left side of a journey dcf ap fem cut blk 5 seems to have a tight tolerance causing pins to bind and break off upon insertion.The broken pin was pulled out with channel lock pliers.The procedure was resumed, after a non-significant delay, with the same device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Manufacturer Narrative
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Medical device problem code the associated device was returned and evaluated.The visual inspection revealed a piece of the pin broke off and the rest of the pin is stuck in the pin hole.The broken piece of the pin was not returned.A few more pins were returned and the visual reveals no signs of damage to them.The cutting block reveals signs of extensive wear and use.This inspection was conducted by naked eye.A functional evaluation performed on the device revealed a pin is stuck in the pin hole and cannot be removed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.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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