SMITH & NEPHEW, INC. GII ARTICULAR INSERTER/EXTRACT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Model Number 71440194 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
Event Type
malfunction
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Event Description
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It was reported that during an office inspection, gii articular insert/extract was noticed to have the tip bent.No case involved.
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Manufacturer Narrative
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Additional information: d4/ h4.Results of investigation: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the returned device is deformed rendering the device inoperable.The device was manufactured in 2008 and shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed item.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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