SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71441144 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/03/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during surgery, the locking mechanism of this item will not tighten fully.The procedure was finished using a smith and nephew back up device.Surgery was not delayed.Patient was not harmed.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms the short pointed floating spikes are severely damaged.There is also visible damage to the cam plate.All these issues would cause the stated failure.The device shows significant signs of wear/usage.The device was manufactured in 2004.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.
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