MDT POWERED SURGICAL SOLUTIONS MIDAS REX® LEGEND FOOTED ATTACHMENT; MOTOR, DRILL, PNEUMATIC
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Model Number AF02 |
Device Problems
Misconnection (1399); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Report confirmed.Evaluation determined that foot is chipped.The likely cause of failure is inadequate preventative maintenance.Previous investigation performed under (b)(4) determined that the likely causes are debris in the collet and improper insertion of the tool.The user manual contains the following warnings ¿do not use a legend attachment if any part of the attachment appears to be bent, loose, missing or damaged.Do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff." in addition, ¿insert dissecting tool into motor collet with a slight rotational motion.A tactile and audible click is observed indicating that the dissecting tool is fully seated.¿ the preventive maintenance/service manual for the legend system specifies service intervals for devices based on the hospital usage level.The maximum specified service interval is 24 months.Device has been in use for approximately 126 months with no record of factory service during this period.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Repair request initiated for device with the report of failure to couple.It was reported that there was no patient impact.Repair escalated to a product event on evaluation due to chipped foot.
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Manufacturer Narrative
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It was also reported that the attachment does not lock onto motor collet and device is kinked.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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Notified date is 2022-01-06.
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