|
Catalog Number 228302 |
Device Problems
Degraded (1153); Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/15/2024 |
Event Type
malfunction
|
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.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: (b)(4) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
|
|
Event Description
|
It was reported from colombia that during an unspecified surgical procedure, it was observed that the arthro pusher/cutter *ea device when using the cutter to cut the suture when activating the trigger, the cut was not immediate so the specialist had to make more traction and force on the trigger to generate the cut, it seems that it is locked internally.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All information has been reported.
|
|
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.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.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 lot number and no non-conformances were 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.
|
|
Search Alerts/Recalls
|
|
|