SMITH & NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74018901 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/07/2020 |
Event Type
malfunction
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Event Description
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It was reported that, after procedure, it was noticed that journey tibial impl impactor was worn and presented a broken plastic.The case had been finished with the same impactor without as scheduled.The patient was not harmed.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirms the impactor bumper is chipped, scratched and has several deep gouges in the plastic.This device was manufactured in 2013.This device exhibits signs of significant wear/usage.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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