SMITH & NEPHEW, INC. JRNY II TKA FEM TRL IMPACTOR SZ1-10; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 74012514 |
Device Problem
Fracture (1260)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/09/2020 |
Event Type
malfunction
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Event Description
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It was reported that the journey ii tka fem trl impactor sz1-10 is snapped in half at the handle.There was no case involved.
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Manufacturer Narrative
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Results of investigation: the device, intended use in treatment, was returned for evaluation.A visual inspection confirmed one of the pegs is broken off the journey fem impact bumper rt and has not been returned.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 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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