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Model Number XOM UNK M-BUR-BLD |
Device Problems
Break (1069); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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A healthcare provider (hcp) reported that the drill with the curved tip keeps breaking mid procedure.When they attempt to change the tip, it also gets jammed in the drill.There was no patient impact.
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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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Event Description
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On follow-up, it was reported that the hand piece did not physically broke.The blade broke near the hub while changing.It was also reported that the bur stuck.
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Manufacturer Narrative
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H3: analysis found visually, the inner shaft was bent until broken and the chevrons on the proximal end of the hub were deformed which likely occurred when it was forcibly removed from the handpiece.The distal outside diameter of the inner hub showed deformation which would have resulted in the bur becoming stuck in the handpiece.The inner hub outside diameter requirement is 0.330¿ +/-0.002 and the actual measurements were 0.330¿ in the undamaged area and up to 0.353¿ in the deformed area, which the latter was out of specification.The inner hub bushing was rough and worn which is an indication of friction between the bushings due to excess speed or aggressive use.There was no allegation of difficulties loading the bur or damage prior to use.The information is consistent with heat induced deformation brought on by excess friction between the subassemblies.H6: fdm b17, fdr c20, fdc d14 no longer apply.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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