Catalog Number CAT02462 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that the anchor was sitting proud and needed to be shaved flush to the bone.There were no adverse consequences and the procedure was completed successfully.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: anchor was inserted and the suture pulled through the anchor and it was split in half.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: excessive cinching/pulling of the suture or 2 removal of inserter before suture adjustment.(b)(4).
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Event Description
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It was reported that the anchor was sitting proud and needed to be shaved flush to the bone.There were no adverse consequences and the procedure was completed successfully.
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Search Alerts/Recalls
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