SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71440005 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal reference number: (b)(4).
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Event Description
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It was reported that, the femoral implant impactor was broken.As this was noticed upon field inspection, there was not patient involvement.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection of the device was conducted and confirmed the head of the device is broken.This device also has extensive wear usage.A review of complaint history revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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.As the device is broken and cannot be reused, the contribution of the device to the reported event could be corroborated 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 probable causes of 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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