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Model Number 1882569HS |
Device Problem
Break (1069)
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Patient Problems
Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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It was reported that during ess procedure, the bur was broken.The broken item might be left in the nose.Intervention was performed.Ct or x-ray imaging will be performed in the future.The procedure was completed with the backup product(s).There was no known patient impact.Additional information received that device was being run at forward motion.Surgeon was working on bone when issue occurred.The device usage was initial.
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Manufacturer Narrative
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H3: product analysis: visually, the inner shaft/spiral wrap connection was broken 3.42 inches from the distal end of the inner hub when returned.A portion of the bur including the distal diamond grit and spiral wrap measured 1.21 inches in length.Overall, there were no missing portions of the device.The hub bushings showed traces of wear and there were striations on the proximal outside diameter of the inner shaft 0.68 inches from the distal end of the inner hub.Functional testing could not be performed due to the broken state of the device.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).H6: previous codes are no longer applied (b17, c20, d14).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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