H3: the product analysis result indicates that there were striations around the outside diameters of the breakpoints, indicating metal on metal contact during use, which would have resulted in the reported event.The breakpoint corresponds to the proximal end of the outer tube in the outer hub.There was no damage to the distal tip.There were no bends or signs of concentricity issues.There was no evidence of improper manufacturing therefore has been ruled out as a likely cause.A review of the global complaint data showed no other similar complaints about this lot number.There was no allegation of a defect prior to use.The information most likely indicates excess pressure was applied while in the handpiece during rotation which caused deformation of the locking area, friction within the assembly, and eventual breakage.The ifu warns: do not use burs above the speed indicated on the bur/blade; excessive pressure applied to the bur/blade may cause damage.H6: additional information suggest that fdm b17, fdr c20 and fdc d14 are no longer applicable to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information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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