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Catalog Number AR-1588BTB |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2021 |
Event Type
malfunction
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Event Description
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During preparation of autograft, 2 of the arthrex tightrope kits were opened and both were faulty.Both devices were immediately removed from the field and inspected by the surgeon and sales rep.Both devices were gathered along with corresponding information and was given to nursing supervisor.Fda safety report id# (b)(4).
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Search Alerts/Recalls
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