SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number 71440005 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka procedure, the tip of two (2) femoral implant impactor had broken.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not harmed as a consequence of this problem.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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The devices were not returned for evaluation; therefore, a device analysis could not be performed.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 based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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 this event was previously identified and addressed; a stress relief process was established for acetal bumpers, samples were tested in order to include the stress relief operation in the manufacturing flow and to include the inspection of stress relief temperature chart to determine compliance.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.These devices are reusable instruments 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 devices 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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