SMITH & NEPHEW, INC. GII SLT 3 MOD TIB CUTBLCK LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440209 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during set up, the pin that hold the part together in the cutting block broke.A s&n backup device was available during surgery.Surgery was not delayed.The patient was not harmed.
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Manufacturer Narrative
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The associated device, intended for use in treatment, was returned and evaluated.A visual inspection confirmed the handle is broken off the gii slt 3 mod tib cutblck lt.The device shows significant signs of wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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 is 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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