|
Catalog Number EMAX2PLUS |
Device Problems
Unintended System Motion (1430); Device-Device Incompatibility (2919); Excessive Heating (4030); Premature Separation (4045)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2023 |
Event Type
malfunction
|
Event Description
|
It was reported by india that during service and evaluation, it was determined that the motor device had an unintended activation/motion and produced heat.It was determined that the attachment could not be engaged and the device made an excessive noise.It was further determined that the device failed pretest for cutter lock assessment, safety assessment, noise assessment and handpiece temperature assessment.It was noted in the service order that during an unspecified surgical procedure, it was discovered that the drill bit devices were not holding on to the straight attachment devices.It was reported that initially the bits would hold for some time, but after using for a while they would come out.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was unknown.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 report 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: d10: concomitant med products and therapy dates: drill bit devices, attachment devices, 1/1/2023 device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition of the device having an unintended/unexpected disengagement was not confirmed.Therefore, an assignable root cause was not determined.However, the device producing heat and having an unintended activation/motion, identified during service and evaluation were confirmed.The assignable root cause was determined to be due to component failure from normal wear.(b)(4).
|
|
Search Alerts/Recalls
|
|
|