Model Number 283512 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number: (b)(6).Udi: (b)(4).
|
|
Event Description
|
It was reported by affiliate via phone that a fms tornado micro handpiece with buttons is broken.No further information available.No surgical delay or patient consequence reported.
|
|
Manufacturer Narrative
|
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.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
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.H10 additional narrative: investigation summary: the device was received and evaluated at the service center.The reported complaint that the device was broken was confirmed.It was further found that the resistance value of the keypad of the handcontrol set was out of specifications.Also the on-button was found to change the direction mode.The handcontrol set was replaced and the device was cleaned, tested and found to be fully functional.However, given the information provided we cannot discern a definitive root cause for the defective keypad of the handcontrol set.A manufacturing record evaluation was performed for the finished device [serial number : (b)(6)] number, and no non-conformances were identified.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 lot: a manufacturing record evaluation was performed for the finished device [serial number : (b)(6)] number, and no non-conformances were identified.
|
|
Search Alerts/Recalls
|
|