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Model Number STEPPED, RATCHET DRILL SLEEVE |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
Event Type
malfunction
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Event Description
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On 11/22/2023, it was reported by a sales representative via (b)(4) that an ar-1510fs-7 ratcheting drill sleeve for flipcutters round top part was separated from the sleeve.This occurred during a case, with no effect on the patient.
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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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