Catalog Number 283812 |
Device Problems
Overheating of Device (1437); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported by the sales rep in switzerland that during an unspecified surgical procedure on an unknown date the shaver handpiece 2.0 with buttons device after connecting the first handpiece showed an error on the display.During the same procedure, the 2nd handpiece device heated up after a short period of case.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 2 for (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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H4: the device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary: the complaint device was received at the r&d.The unit involved in this complaint has been received and per s&r technicians, these units fall under capa and escalation, therefore no service/wo will be performed.These units presented a failure in the motor; however, as the motor cannot be disassembled to perform a repair, the devices must be discarded.The front seal of the motor is allowing saline to enter the motor during use.This causes the handpiece to stop functioning.This fault affects the reliability of the handpiece but does not adversely impact patient safety.A manufacturing record evaluation was performed for the finished device serial number: (b)(6), and no non-conformances related to the reported complaint condition were identified.The products (283712 & 283812) produced with the original design (rev a) are not serviceable.The root cause is attributed to manufacturing involving a design change.There is a capa associated with this product code, most of the complaints received to-date are related to failed motors with evidence of water intrusion and manifested as malfunctioning or seized motors, therefore; the devices are under service discontinuation.This product issue is already being addressed by depuy quality system.Further investigation and assessment are covered under the capa in our quality system.Depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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Search Alerts/Recalls
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