SMITH & NEPHEW, INC. STEM IMPACTOR ROD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71364011 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation. a visual inspection confirms the device¿s threads appear to be stripped and excessively worn.This device also has significant signs of wear/usage.The manufacturing date for this device is 2002.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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Event Description
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It was reported that the threads of the stem impactor rod were stripped.Event occurred after procedure, with no patient involved.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the threads are damaged on the device.The end of the threaded section that interfaces with the threaded driver hole of the hip stem was deformed.The deformation may have been caused by, but is not limited to: transfer of bending or impact loads applied through the threaded tip of the impactor in excess of the material strength or cross threading.The device was manufactured in 2008.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and 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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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