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Catalog Number 321-25-01 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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As reported, while reaming the glenoid with the reverse pilot starter reamer, the pilot tip portion of the reamer broke off in the male patient¿s glenoid.A midas was used to bur out a portion, however, the piece seemed to go deeper into glenoid and surgeon is unsure the entire piece was removed, a portion is believed to be left in patient.Patient was last known to be in stable condition following the event.Device is to be returned.
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Manufacturer Narrative
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(h3) the broken device reported was likely the result of applying a bending moment to the reamer during use, which led to brittle fracture of the pilot tip fracture.(h9) if action reported to fda under 21 usc 360i(f), list correction/removal reporting number: z-2663-2017, z-2664-2017, z-2665-2017, z-2666-2017, z-2668-2017, z-2668-2017.
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Search Alerts/Recalls
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