SMITH & NEPHEW, INC. LEGION HINGE TIBIAL STABILIZING TOOL; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, POROUS, COAT, POLY/MET/POLY
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Model Number 71434465 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/13/2020 |
Event Type
malfunction
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Event Description
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It was reported that during a rep training bone saw lab, the device was being used and the tip of the instrument cracked and broke off.Since this was during a rep training, there was no patient involved and no harm done to any existing case.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the device tip broke off.The broken piece was not returned.The device shows significant signs of wear/usage.The device was manufactured in 2012.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.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.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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