Catalog Number CAT02462 |
Device Problem
Cut In Material (2454)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known at this time because lot number could not be confirmed however, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported the suture tape cut through the anchor.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: suture tape cut through the anchor probable root cause: "design: anchor design does not facilitate suture adjustment.Anchor barbs too aggressive for suture.Anchor does not have adequate bone engagement feature.Manufacturing: anchor not manufactured to specification.Application: excessive force applied to suture.Wrong suture type used.Removal of inserter before suture adjustment.Anchor seated too deep, suture cut".The device manufacture date is not known.(b)(4).
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Event Description
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It was reported the suture tape cut through the anchor.
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Search Alerts/Recalls
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