SMITH & NEPHEW, INC. GII INTRA TIB ALIGNMENT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440200 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka, a gii intra tib alignment had difficult to pass through.The procedure was able to be completed with the same device.Surgery was not delayed.Patient was not harmed.
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Manufacturer Narrative
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H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection was performed and confirmed the intra tib alignment has a damaged bar on the reamer holder sub-assembly of the device.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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