SMITH & NEPHEW, INC. GII MIS DCF ALIGN GDE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 71441144 |
Device Problems
Defective Device (2588); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/28/2020 |
Event Type
malfunction
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Event Description
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It was reported that the doctor needs to replace these genesis alignment guides, as they are no longer locking to the block.No case or patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode but could confirm that the device has scratches, burrs and nicks on it.A functional evaluation of the returned product confirmed the stated failure mode.The device was paired with the mating part but could not function, rendering the device inoperable.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.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.We consider this investigation closed.
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