SMITH & NEPHEW, INC. REF TRIAL SHELL HANDLE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71362297 |
Device Problems
Fracture (1260); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during thr surgery, the tip of a ref trial shell handle became cross threaded and broke off (outside the patient).No surgical delay was reported to occur, and the procedure was completed with a smith and nephew back up device.No patient harm was reported to occur due to this incident.
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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 confirms the tip on the device became cross threaded and broke off rendering the device inoperative.This device exhibits signs of significant wear/usage.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.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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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