SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71368569 |
Device Problems
Break (1069); Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that, r3 offset impactor was rusted and broken.As this was noticed upon field inspection, there was not patient involvement.
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Manufacturer Narrative
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H6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned r3 offset impactor confirmed the handle is broken and there is discoloration in the metal.This device also has extensive wear usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch.At this time, we do not have reason to suspect that the product failed to meet any product 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 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 for future complaints and investigate as necessary.We consider this investigation closed.
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