Model Number BURR ATTACHMENT 2.35 MM |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
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 11/30/2023, it was reported by a sales representative via (b)(4) that an ar-300b burr attachment was defective and did not allow burrs to slide into the handpiece.This was discovered during the case with no patient harm.
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Search Alerts/Recalls
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