SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Catalog Number 71440145 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/03/2020 |
Event Type
malfunction
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Event Description
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It was reported that before procedure it was noticed that the reamer was dull.No procedure-related.
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Manufacturer Narrative
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The device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the gii p/s cons housing ream dome shows nicks and scratches.The device shows significant signs of wear/usage.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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