SMITH & NEPHEW, INC. MI OFFSET REF IMP SD SHAFT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
|
Back to Search Results |
|
Model Number 71364023 |
Device Problem
Material Deformation (2976)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/15/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that, during surgery, instrument stripped and would not work properly.Procedure continued with the same device without a delay or an injury.
|
|
Manufacturer Narrative
|
The device, used in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.
|
|
Manufacturer Narrative
|
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection confirmed the hex tip is stripped causing stated failure.The device show significant signs of wear/usage.A complaint history review found related failures; 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.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.H3, h6, h10.
|
|
Search Alerts/Recalls
|
|
|