Catalog Number 283512 |
Device Problems
Overheating of Device (1437); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H4: the device manufacture date is unknown.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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Event Description
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It was reported by the healthcare professional in brazil that during an unspecified surgical procedure performed on (b)(6) 2023 it was observed that the micro tornado hp w handcontrol had heat and the blade not fixed (the ring had decreased in size).There was no surgical delay and no harm to the patient.No further information is available.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: visual : cord damaged cable,electrical.Functional : moisture/water damage motor(s).Per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history review: a manufacturing record evaluation was performed for the finished device serial number, and no non-conformances were identified.
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Search Alerts/Recalls
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