|
Model Number EMAX2PLUS |
Device Problems
Vibration (1674); Noise, Audible (3273); Excessive Heating (4030)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2022 |
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 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.Additional narrative: reporter's phone number was not provided.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi ¿ (b)(4).
|
|
Event Description
|
It was reported from india that after an unspecified surgical procedure it was observed that the motor device had vibration, there was sound coming from the hose, and the device had heating issues.This event did not occur during surgery.There was no patient involvement.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 2022.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.During repair, an evaluation was performed and it was determined that the motor device had heat, was making excessive noise, and had unintended activation/motion.It was further determined that the device failed pretest for safety assessment, noise assessment, and handpiece temperature assessment.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.The reported condition of vibration was not confirmed.Correction h10: it was inadvertently reported that the device had been returned in the initial report.Please note that the device was not retuned until after the initial medwatch report was submitted on (b)(6) 2022.
|
|
Search Alerts/Recalls
|
|
|