SMITH & NEPHEW, INC. RDCE FRCPS W/ PTS BRD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71173377 |
Device Problems
Material Deformation (2976); Material Twisted/Bent (2981)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2020 |
Event Type
malfunction
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Event Description
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It was reported that the point of the clamp is bent.It is unknown when this failure occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.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 have no reason to suspect that the product failed to meet any product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damaged 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 information 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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