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 Problems
Detachment of Device or Device Component (2907); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, while using the universal extractor to remove a journey dcf ap fem cut blk 5 from patient during a tka surgery, it was noticed that a part of its rotating mechanism came apart.The procedure was completed, without any delay, using the same device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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The associated device was returned and evaluated.A visual inspection of the returned device reveals burrs and gouges in the metal.The device does show signs of excessive wear and use.The visual inspection from the returned device did not reveal any pieces detached from the device since the device was returned reassembled; however, the picture provided revealed that the screw and the anchor were detached from the device, at the time of the event.A functional evaluation revealed the turn knob is seized in place and will not turn.This failure occurred because the device was reassembled before being returned.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 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.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 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 future complaints and investigate as necessary.We consider this investigation closed.
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