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Model Number PHALANGEAL REAMER, 22MM |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2023 |
Event Type
malfunction
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Event Description
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On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8944mr-20 metatarsal reamer and an ar-8944mr-22 metatarsal reamer, and an ar-8944pr-20 phalangeal reamer and an ar-8944pr-22 phalangeal reamer were all getting dull.This was discovered during an unspecified procedure, with no reported adverse event or patient harm.
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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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Search Alerts/Recalls
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