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Model Number 24MM +2 LAT BASEPLATE, MODULAR |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/25/2021 |
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.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 user error of the device due to misaligned insertion.
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Event Description
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On 10/26/2021 it was reported by a sales representative via phone that an ar-9561-25s center screw and ar-9560-24-2 modules baseplate did not seal together on the back table using the morse taper.The case was completed by opened a new baseplate and screw.
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Search Alerts/Recalls
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