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Model Number 1883070HS |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that during procedure scrub nurse connected the new burr to the debrider handpiece and surgeon before using it on patient pressed the footpedal.The spring of the burr tip came off.It was further reported bur was broken the moment surgeon pressed the footswitch.There was no patient involvement.
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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.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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Manufacturer Narrative
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H3: product analysis stated visually, the device was returned in an open pouch.The pouch was open from 2 of 4 sides.There was no damage to the hubs (inner and outer), and bushings and seal were intact when returned.The device had traces of contamination near the curved area of the device.The distal end of the bur was damaged, there was an opening at the distal end that measured 0.147 inches (horizontally).The spiral wrap was stretched/expanded passing the distal end of the outer tube.The expanded part measured 0.579 inches from the distal end of the outer tube to the expanded part.There was also a fragment of a broken/dislodged spiral wrap, and this part measured 0.521 inch in length.Functional testing could not be performed due to the broken state of the device.A review of the global complaint data showed one similar complaint about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).H6: previously applied codes fdm b17, fdr c20, fdc d14 img g04041 codes are no longer applicable.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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