SMITH & NEPHEW, INC. GII UNIVERSAL EXTRACTOR; PRST,KN,PAT/FEM,SEMCNSTR,UNCM,POR,COAT,POL/MET/POL
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Model Number 71440366 |
Device Problem
Break (1069)
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Patient Problem
Injury (2348)
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Event Date 08/26/2020 |
Event Type
Injury
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Event Description
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It was reported that during surgery (instrument inside the patient) device broke while removing cutting block.The procedure was completed without delay with the same device.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the gii universal extractor confirms the device fractured into three pieces.All pieces were returned for evaluation.The device was manufactured in 2018.This instrument exhibits signs of extreme use and wear.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.A review of complaint history on the listed part revealed no prior complaints for the listed batch number with the same failure mode.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 risk management files found that the reported failure was documented appropriately.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.
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