If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the chuck of the device had seized.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is user error/misuse/abuse.Udi: (b)(4).
|
It was reported from (b)(6) that during service and evaluation, it was determined that the chuck with key device seized/frozen, the color band was chipping/fading, the bearing was worn, moving parts of the device were not moving smoothly, and there was component damage.It was further determined that the device failed pretest for check for free movement, check for machine coupling, and check the drill chuck.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 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|