SMITH & NEPHEW, INC. ACCORD TENSIONER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71360020 |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/15/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during procedure, the accord tensioner will not adequately take and hold the cable.There was no procedural delay to the case because a smith & nephew back up accord tensioner was available.The patient was not harmed.
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Manufacturer Narrative
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The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2016 and shows signs of extensive wear / usage.The functional evaluation confirmed the stated failure mode.The device will not hold tension as intended.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
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