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Model Number 71634005 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during surgery, the nail cap 5mm cannot fit into the tibia nail.The procedure was finished with a smith and nephew back up device without delay.The patient was not harmed.
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Manufacturer Narrative
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Internal complaint reference 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 was conducted and confirmed that the inner part of the nail cap has deformation, rendering the device inoperable.This device also shows signs of significant wear and usage.A review of complaint history did not reveal similar events for the listed batch and part number.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.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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.Possible causes could include but not limited to surgical technique used or user/procedural variance.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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Search Alerts/Recalls
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