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Model Number APOLLORF¿ XL90, ASPIRATING ABLATOR 90° |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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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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Event Description
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On 08/03/2023, it was reported by an arthrex employee via sems that an ar-9821 apollorf xl90s black colored coating was flaking off the sides of the probe.This occurred during a hip arthroscopy procedure on (b)(6) 2023, there was no injury to the patient however the doctor spent an extra two minutes retrieving the pieces out of the hip joint and finished the case with a ar-9821.
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Search Alerts/Recalls
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