SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number 71368569 |
Device Problems
Degraded (1153); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
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Patient Problems
Injury (2348); No Information (3190)
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Event Date 12/05/2018 |
Event Type
malfunction
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Event Description
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It was reported that, during surgery, device was not working properly.No back-up was available.
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Manufacturer Narrative
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The associated complaint device was returned and evaluated.A visual inspection of the returned r3 offset impactor indicated that the thumb release no longer holds.A functional evaluation indicated that the linkage does not function smoothly.The plastic impactor tip is missing.Failure to use this tip may result in the distal linkage section to become damaged and the overall device not functioning as intended.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.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.
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Search Alerts/Recalls
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