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Model Number KNOTLESS HIP FIBERTAK |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/15/2022 |
Event Type
malfunction
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Event Description
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On 11/21/2022, it was reported by a sales representative via phone that an ar-3638h knotless hip fibertak fork like tip on the inserter broke upon implanting the anchor.This was discovered during a hip arthroscopic labral repair on (b)(6) 2022.Broken fragments were not removed from the patient.
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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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Search Alerts/Recalls
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