SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PRSTHSIS,KN,PATLLO/FMROTIBL,SMI-CNSTRAIND,UNCMNTD,PRS,COATD,POLYMR/METAL/POLYMR
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Catalog Number 71441144 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2018 |
Event Type
malfunction
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Event Description
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It was reported that during surgery the align guide did not latch properly.Smith and nephew backup used.No delay to procedure, no injury to patient.Device will be returned.
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Manufacturer Narrative
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The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device functioned as intended with a mating part and passed the gage check.The device exhibits signs of moderate wear/usage.A review of complaint history did not reveal additional complaints for the listed batch for 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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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Manufacturer Narrative
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Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there was not a previous incident from the same or equivalent device that has caused a serious injury, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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