SMITH & NEPHEW, INC. REPAIR, STEM IMPACTOR ROD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 71364011R |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/18/2020 |
Event Type
malfunction
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Event Description
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It was reported that the stem impactor rod was found stripped.No procedure-related.
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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 stem impactor rod confirms the tip threads are damaged.The device is manufactured in 2003.The device exhibits signs of extreme wear and use.A review of complaint history on the listed part revealed no prior complaints for the listed batch 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.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.
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