SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71433345 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2021 |
Event Type
malfunction
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Event Description
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It was reported that a gii spc reamthru cr tr sz 5 lt has a crack on the trial.No patient involved.
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Manufacturer Narrative
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H6: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode but could confirm that the device has scratches on it and shows signs of wear and tear.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.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.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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