SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PRSTHSS, KN, PTLL/FMRTBL, SM-CNSTRND, NCMNTD, PRS, CTD, PLYMR/MTL/PLYMR
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Model Number 71440145 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that a housing reamer dome has become dull from use.No case involved.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.A visual inspection was conducted and confirmed the housing reamer dome is dull.The lot number cannot be read on the device.This device shows signs of extreme wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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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