SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71368569 |
Device Problems
Fracture (1260); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a thr surgery, while inserting the cup, the screw in locking mechanism of a r3 offset impactor could not disengage from the implant.After torque force, it was released, but the bolt connection drive snapped.All of the broken pieces were accounted for and came out with the instrument.The procedure was completed, with a non-significant delay, using the same device.The patient was not harmed as a consequence of this problem.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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Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Case-(b)(4).
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the tip of the device that holds the reamer in place broke off the device.The broken piece was returned.The device shows signs of significant wear and use.A functional evaluation did not reveal the issue with the locking mechanism due to the broken tip of the device.A review of complaint history based on the historical data 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.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 a similar event was previously identified, and prior actions were performed.In addition, it has been concluded that there is a potential for breakage if used after the expected lifetime or excessive force is used as this device is a reusable instrument and it is expected to wear over time.Also, the failure rate of this issue is within expected and documented in the risk file.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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