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Model Number FIBERTAK |
Device Problems
Break (1069); Output Problem (3005)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/18/2022 |
Event Type
malfunction
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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 6/10/2022, it was reported by a sales representative via email that an ar-3638 knotless fibertak inserter tip broke off in glenoid while inserting the anchor and passing the suture.Everything was removed from the patient and a second ar-3638 knotless fibertak was opened.This time, the anchor would not tighten down and was also removed.This was discovered during a shoulder arthroscopy labral repair on (b)(6) 2022.
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Search Alerts/Recalls
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