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Model Number 321-35-46 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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It was reported that while reaming the glenoid, it fractured off the square piece that attaches to the tri drive.Rep believes the tech did not fully seat the reamer on the tri drive and when he started reaming.Nothing was damaged on the patients end.No fragments, parts or pieces fell into the patient.It fractured outside the 81 y/o male patient and from the tri drive connection piece most distal.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Device is returning.
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Manufacturer Narrative
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(h3) the broken cannulated reamer reported may have been due to incomplete seating of the reamer on the tri-driver prior to use, which led to fracturing of the reamer post during reaming.Section h11: the following sections have corrected information: (h6) component code: 912, post.
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Search Alerts/Recalls
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