Product analysis of part# 9560524 ; lot# my22l001 service report states that the thread of the handle screw was deformed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Information was received from multiple sources (manufacturer representative, user facility) regarding an event happened during servi cing of the reported product.It was reported that, the flex arm does not close anymore.There was no patient involved during this event.No further complications reported.
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