SMITH & NEPHEW, INC. LGN 6 DEG VALG COL NTRAL S3-8; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, METAL/POLYMER
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Model Number 71434404 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during inspection for a tka procedure, the collet was stuck and wouldn't move.There was no delay or patient harm reported.Procedure was completed using a smith and nephew back up device.
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Manufacturer Narrative
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The device, intended for use in treatment was returned for evaluation.A visual inspection confirmed that the collet is stuck which causes it not properly function.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.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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