Catalog Number 283512 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2023 |
Event Type
malfunction
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Event Description
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It was reported by the sales rep that on 12/26/2023 the micro tornado device heats up.There were no adverse patient consequences reported.No additional information was provided.
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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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the device manufacture date was unknown udi: (b)(4).
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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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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 complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device, and no non-conformance was identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.
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Manufacturer Narrative
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D4: the expiration date has been added 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.D4; the lot number 1417m4464r has been updated to serial number (b)(6).
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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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: ¿ functional : damaged connector.Per service reports, this complaint cannot be confirmed.The circuit board was replaced to resolve the issues.After repair, the device was found to be working according to the specifications.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.
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Search Alerts/Recalls
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