Model Number 283512 |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/18/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional narrative: the serial number was unknown; therefore, the manufacturing site name was unknown.Udi: (b)(4).(21) incomplete.The serial number was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
|
|
Event Description
|
It was reported by the affiliate in (b)(6) that during an arthroscopy surgery on (b)(6) 2021, it was observed that the micro tornado hp w handcontrol device could not stick the blade in.There were no adverse patient consequences reported.No additional information was provided.
|
|
Manufacturer Narrative
|
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.D4: the serial number was reported as unknown on the initial report; and has been updated accordingly.Udi: (b)(4).
|
|
Manufacturer Narrative
|
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 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.The device manufacture date was reported as unknown on the initial report; and has been updated accordingly.
|
|
Manufacturer Narrative
|
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 mewatch will be filed as appropriate.H10 additional narrative: investigation summary = > the complaint device was received at the service center and evaluated.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: ¿ visual : damaged seals/o-rings - broken seal the defective parts were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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 = > manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
|
|
Search Alerts/Recalls
|
|