SMITH & NEPHEW, INC. RDCE FRCPS W/ PTS BRD; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71173377 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/08/2020 |
Event Type
malfunction
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Event Description
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It was reported during the procedure, that the pointed forceps do not align.The procedure was completed without delay and backup from smith & nephew was available to finish the surgery.No patient injury ot other complications were reported.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.The visual inspection of the returned forceps confirms the tip is bent causing the stated failure.This device was manufactured in 2020.This device shows signs of significant wear and usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.Our reference number: case-2020-00022805-1.
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