(b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.It was further determined that the saw blade device most likely came in contact with a metal part, respectively something metallic was sawn with the blade.The assignable root cause was determined to be due to improper reprocessing and handling, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
It was reported from (b)(6) that during service and evaluation, it was determined that the saw blade device was deformed and bent.It was further determined that the saw teeth were bent and worn out.It was noted in the service order that the device did not have an adequate cut.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
|