SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 7 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71433347 |
Device Problems
Fracture (1260); Material Deformation (2976); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fracture and deformation of the fixation rails in the ream through slot of the femoral trial, causing it to be stuck.The device shows signs of extensive use.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.
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Event Description
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It was reported that, during tka surgery, a gii spc p/s hous collet s 3-8 got stuck in the gii spc reamthru cr tr sz 7 lt.The surgery was resumed, after a non-significant delay, with a back-up device.The patient was not injured as consequence of this problem.The investigation found that the fixation rails in the ream through slot of the gii spc reamthru cr tr sz 7 lt were fractured.
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