In this complaint a bur came out of a handpiece and was removed before it could be swallowed or aspirated.
There was no injury to the pt.
The bur is not intended to come out of the handpiece therefore the handpiece malfunctioned.
There has been a report of the same malfunction where a physician decided surgical removal of the bur was necessary to preclude permanent damage to a body structure or permanent impairment of a body function.
Per the medical device reporting regulation this meets the definition and is reportable.
The set is of midwest mfr.
Quiet air sets do not have a date code marking.
Based on the last repair date, this set had been in use for 5 months at the time of the reported failure.
Visual observations-excessive debris and corrosion everywhere.
Rep could not unscrew the cap.
The repair department had to use special tools to unscrew the cap.
Microscopic exam of the set showed the following: debris inside the chuck no visible crack inside the chuck.
Conclusions: the reported problem of bur walkout was duplicated in an aggressive cutting test.
Based on the external appearance of the handpiece co beleives that poor maintenance is the cause.
Both handpieces returned by this customer exhibited similar problems and appearance.
Recommendations for corrective action suggest corrective action to reduce or eliminate recurrence of this problem.
Replace the handpiece.
Review maintenance and repair practices with customer.
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