Model Number BURR ATTACHMENT 2.35 MM |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2023 |
Event Type
malfunction
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Event Description
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On 10/11/2023, it was reported by a sales representative via (b)(4) that an ar-300b burr attachment has a lock and unlock button which will move, but the burr will not advance to its appropriate depth and lock in correctly.It was involved in a case.Patient was not affected.
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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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