|
Catalog Number EMAX2PLUS |
Device Problems
Output below Specifications (3004); Excessive Heating (4030); Fail-Safe Did Not Operate (4046)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: e1: reporters phone number was not provided.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).
|
|
Event Description
|
It was reported from taiwan that the motor device was running at a low speed and was heating up.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2023.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.The motor device was evaluated and the reported condition that the device was heating up and the motor was running at a low speed was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the console of the device was displaying an e5 error code (handpiece fault), the flex circuit was damaged, and the device runs in the locked position.It was further determined that the device failed pretest for motor thermistor assessment, and safety assessment.The assignable root cause of these conditions was determined to be traced to the user, which is user error.
|
|
Search Alerts/Recalls
|
|
|