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Model Number XOM UNK MICDEBBUR |
Device Problems
Break (1069); Failure to Disconnect (2541); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3: analysis results were not available as of the date of this report.A supplemental report will be submitted when analysis is complete.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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Information received by medtronic that the bur got stuck in the mechanism and can't be removed.Analysis of handpiece confirmed that base piece of the drill was in the collet.No patient involved.
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Event Description
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Additional information received, bur was intact without any damage as it was stuck in the handpiece and could not be removed.
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Manufacturer Narrative
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H3: product analysis found that, visually, the shaft was broken when returned.The broken shaft measured 0.572 inches from the distal end of the inner hub to the broken point.The seal (green seal) was dislodged, and the spring was intact inside the diameter of the inner hub (at the proximal end of the hub).The proximal end of the hub (chevrons) was damaged.The distal end of the inner hub was also deformed (the outside diameter of the inner hub).The outside diameter of the inner hub shall measure 0.330 ± 0.002 inches and measured 0.330 inches in undamaged area and up to 0.372 inches in deformed area which was out of specification.Functional testing could not be performed due to the broken state of the device.H6:previous codes b21,21,d16, and g04041 are no longer valid.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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