The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the trigger of the device was not moving smoothly.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.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).
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It was reported from (b)(6) that during service and evaluation, it was determined that the trigger of the sagittal saw with key device was not moving smoothly, and the bearing was worn.It was further determined that the device failed pretest for check proper function of the trigger, and check for leakage.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 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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