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Model Number MODULAR POST, 30MM |
Device Problem
Fitting Problem (2183)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/28/2022 |
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to wear and tear.
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Event Description
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On (b)(6) 2022, it was reported by a sales representative via email that ar-9582-30 modular post and an ar-9580-2420-2s augmented baseplate did not lock.Surgeon attempted to implant them multiple times but it would not seat.This was discovered during a reverse total shoulder replacement procedure on (b)(6) 2022.Additional information received on (b)(6) 2022: surgeon removed both the baseplate and post from the patient and used an ar-9580-2410-2 baseplate and ar-9582-30 modular post to complete the case without further issues.Nothing broke off inside the patient.
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Search Alerts/Recalls
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