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Model Number KNOTLESS HIP FIBERTAK |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/19/2021 |
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 (b)(6) 2021, it was reported by a sales representative via sems that an ar-3638h knotless hip fibertak anchor came out of the package with no purple line indicating where to fold the suture over for shuttling.Without the purple line it was difficult for the surgeon to be sure and confident in shuttling, which resulted in the repair stitch sliding out of the loop while shuttling and was left with just the #2 repair stitch.To complete the case the surgeon then had to dunk this stitch into a pushlock anchor.
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Search Alerts/Recalls
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