Model Number GALILEO® LAG SCREW INSERTER |
Device Problems
Loose or Intermittent Connection (1371); Material Separation (1562)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2022 it was reported by a sales representative via sems that an 5030-000 multiple pieces of the lag screw inserter handle loosened and fell apart.This was discovered during use in a troch nail procedure on (b)(6) 2022.
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Manufacturer Narrative
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The complaint is confirmed.One unpackaged 5030-000 was received for evaluation.Visual inspection identified no apparent issues with the device.Further inspection revealed the outer hub sheath could be unscrewed, and the pin that held the inner hub could be removed by tapping the device against a surface.This caused the entire hub assembly to come apart.This issue is known and has been addressed in aos internal record eco-1596.Further monitoring will be performed for similar complaints post implementation of the eco.
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Search Alerts/Recalls
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