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Model Number KNOTLESS HIP FIBERTAK |
Device Problems
Output Problem (3005); Positioning Problem (3009)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/28/2022 |
Event Type
Injury
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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 10/31/2022, it was reported by a sales representative via email that (4) ar-3638h knotless hip fibertak anchor would not seat as the surgeon was tensioning the construct and would pull out.Surgeon spent 45 minutes constantly trying to implant anchors with no success.This was discovered during a hip labral repair on (b)(6) 2022.Additional information received on 12/5/2022: due to the 45 minutes delay, patient was administered additional anesthesia.
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Search Alerts/Recalls
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