SMITH & NEPHEW, INC. PATELLA RESECTION GUIDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71440391 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during a tka procedure, using a patella resection guide, the saw blade would not fit in saw capture.The procedure was successfully completed without delay using a smith+nephew back-up device.No patient injury or other complications were reported.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection was performed and confirmed the patella resection guide has loose screws and worn teeth on the device.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.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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