Model Number BURR ATTACHMENT 2.35 MM |
Device Problem
Fitting Problem (2183)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/14/2024 |
Event Type
malfunction
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Event Description
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On 3/14/2024, it was reported by a sales representative via (b)(4) that an ar-300b burr attachment could not be locked into the mis instrumentation system.This was discovered during a bunion/akin correction procedure on (b)(6) 2024.
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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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