Catalog Number 283512 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).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.Udi: (b)(4).
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Event Description
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It was reported by the affiliate via phone that when plugging the blande in the micro tornado hp w handcontrol it falls down.No additional information provided.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Updated data- device available for evaluation.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Investigation summary : the device was received and evaluated at the service center.The reported complaint that blade falls off the device was unable to be confirmed.However, it was found that the motor did not turn smoothly as it was corroded.It was also noisy during operation.Also the resistance value of the keypad of the handcontrol set was out of specifications.As a result, the keypad assembly was found to be not responding properly.The motor and the handcontrol set were replaced to correct the identified failures.The device was cleaned, tested and found to be fully functional.Fluid ingress into the system and contact with the motor is responsible for the corrosion of the motor.The corroded motor has a tendency to stick and not turn, hence would have resulted in noisy operation.However, given the information provided we cannot discern a definitive root cause for the defective keypad.Since the reported complaint could not be confirmed, a root cause cannot be determined for the same.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 08/15/2017 and passed all functional testing before being returned to the customer.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.Udi: (b)(4).
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Search Alerts/Recalls
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