SMITH & NEPHEW, INC. LAG DRIVER RETAINING ROD ASSY; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 71674087 |
Device Problem
Material Deformation (2976)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2020 |
Event Type
Injury
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Event Description
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It was reported that during surgery with lag/comp screw kit 95/90 and lag driver retaining rod assy, while inserting a lag screw, the retaining rod came out and the guide pin stuck in acetabular, all three devices were removed from the body, dent was found on the retaining rod; the procedure was successfully completed with minimal delay with a change in technique, no other complications were reported.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection confirmed the lag driver retaining rod assy is dented.The device shows 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 any manufacturing abnormalities that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.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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