ARTHREX INC. IMPLANT SYSTEM HAND/WRIST INTERNALBRACE LIGAMENT AUGMENTATION REPAIR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number AR-8978-CP |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/24/2021 |
Event Type
malfunction
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Event Description
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Arthrex internal brace kit (ar-8978-cp) was brought in for a surgical procedure.Kit had two 3.5mm drill bits instead of one 3.0mm and one 3.5mm.Surgeon drilled a hole larger than intended with the 3.5mm drill bit resulting in the use of a larger anchor than anticipated.Procedure was completed and the outcome was not affected by the packaging error.Fda safety report id# (b)(4).
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