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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Catalog Number 71440145 |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/11/2020 |
Event Type
malfunction
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Event Description
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It was reported that the devices need replacement from wear and tear.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 can¿t 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 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.
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Search Alerts/Recalls
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