The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to wear from loctite degradation which is normal use and servicing over time and improper cleaning, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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It was reported that the quick coupling device would not stay connected to the
handpiece.It was reported that other attachments would stay connected to the handpiece.During in-house engineering evaluation, it was determined that the device came apart, missing planetary wheels, missing start disc, worn out clamps, corroded internal parts and had worn bearings.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 this event is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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