SMITH & NEPHEW, INC. NONRIM SPEED PIN 65 STERILE; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number 74013480 |
Device Problem
Illegible Information (4050)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/06/2019 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, after the distal femoral cutting, there were the shaving substances.The marking of the pin was damaged and vanished, so the shavings were considered they were from the pin.This issue was found after screwing the pin and did not affect the surgery.Everything was removed from patient.Delay less than 30 minutes and no injury.
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Manufacturer Narrative
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The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The devices had numerous score marks on the shaft where material had been removed, making the laser markings barely visible.The devices were manufactured in 2018 and exhibits signs of extensive wear/ usage.A review of complaint history did not reveal additional complaints for the listed batch.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 complaint will be reopened.No further investigation is 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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