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Model Number PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.Two ar-5008, batch 012046 probes were received for investigation.Visual inspection identified that the black coating on the ar-5008 probes had rubbed off in some locations along the shaft.This failure mode is investigated further under an ncr.
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Event Description
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On 08/17/2021, it was reported by a sales representative via sems that two ar-5008 (line#1) 012045 and (line#2) 012046 black probe the finish was rubbing off onto the 4x4 sponge. this was discovered before a shoulder procedure on (b)(6) 2021.The case was completed using a different ar-5008.
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Search Alerts/Recalls
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