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Model Number ANGLED REAMER SLEEVE, 10° |
Device Problem
Material Fragmentation (1261)
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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-9597-10 reamer sleeve is getting caught and producing debris into patient.This was discovered during use in a case debris produced, no adverse effect to the patient.Additional information requested on 12/19/2023.
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Search Alerts/Recalls
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