SMITH & NEPHEW, INC. LGN AP FEM CUTTING BLK SZ 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71434409 |
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 01/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference number: (b)(4).
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Event Description
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It has been reported that, during a tka, the lgn ap fem cutting blk sz 4's chia ball was falling out.Preventing the device from use it.Surgery was performed, without any delay, with the same device.No patient complications were reported.
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Manufacturer Narrative
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Section h3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed the detachment of the plunger.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 the device or 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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