SMITH & NEPHEW, INC. LGN OX CONSTRAIN FEM TRL 5 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71431175 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that a legion screw-on distal femoral wedge trial 10mm size 5 broke off from a legion oxinium constrained femoral trial size 5 right.Surgery was completed with a backup device, without any delay.Instruments were outside the patient.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection of the lgn ox constrain fem trl 5 rt confirms the screws from the lgn dis fem wdg trl 10mm sz 5 are stuck inside the device.The device exhibits signs of significant wear and usage.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.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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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