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Model Number XOM UNK BLADE |
Device Problems
Break (1069); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3:visually, the shaft was broken 0.55 inches from the distal end of the hub when returned.There was deformation in the distal outside diameter of the hub.The outside diameter of the inner hub shall be 0.330 ± 0.002 inches and measured 0.329 inches in the undamaged area and up to 0.343 inches in the deformed area which was out of specification.There were traces of wear on the hub bushing.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 physi cal damage).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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It was reported that during use, the shaver was used at the right setting with the right blade but blade stuck inside m5 handpiece.They used another m4 handpiece to complete the procedure.There was no patient impact.As per the m4 handpiece analysis findings broken blade stuck inside the handpiece.
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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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Search Alerts/Recalls
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