Model Number BTB TIGHTROPE W/ DEPLOYING SUTURE |
Device Problem
Fitting Problem (2183)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces to the construct during use.
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Event Description
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On 06/15/2022, it was reported by a sales representative via sems that an ar-1588btb-j tightrope did not seat correctly during a procedure.The tightrope button was flipped onto the femoral cortex and shortened as the bone block entered the tunnel.The tightrope then would not shorten any further causing the button to not fully seat on the bone.The tightrope was removed by the surgeon cutting the sutures.
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Search Alerts/Recalls
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