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Model Number 9560524 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2024 |
Event Type
malfunction
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Event Description
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Information was received from a manufacturer representative regarding an event which occurred prior to use.It was reported that the arm would not tighten. there was no patient involvement reported.
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Manufacturer Narrative
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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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Manufacturer Narrative
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H3: product analysis: part #: 9560524, lot#: my09l001.Visual inspection revealed the flex arm was returned with no missing or disassembled components.Functional evaluation confirmed the handle was able to be tightened and loosened but the flex arm was not able to maintain the position once tightened.The internal locking mechanism seems to be worn from repeated use.H6: fdm and fdr codes are updated.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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Search Alerts/Recalls
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