SMITH & NEPHEW, INC. MI Z HANDLE ACET REAMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71364073 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a thr surgery, a minimal incision z handle acetabular reamer was wobbling.Surgery was performed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection of the returned device did not confirm the stated failure.A functional evaluation was conducted and confirms once the device is fully assemble, the device does wobble.A review of complaint history did not reveal similar events for the listed device.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.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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