FDA Adverse Event Malfunction Summary report: N

TRADITION PUSH BUTTON FIBER OPTIC HS HANDPIECE

MDR report key: 4231818 · Received October 15, 2014

Report

Report Number: 1419322-2014-00065
Event Type: Malfunction
Date Received: October 15, 2014
Report Date: September 15, 2014
Manufacturer: DENTSPLY PROFESSIONAL
Product Code: EFB
PMA / PMN Number: K963050
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING A SIMILAR DEVICE THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. OBJECTIVE EVIDENCE SUPPORTED THE REPORTED COMPLAINT. HOWEVER, DENTSPLY WAS UNABLE TO DETERMINE HOW THIS OCCURRED. THE HANDPIECE WAS RECEIVED WITH THE CAP HAND TIGHTENED ONTO THE HEAD. MICROSCOPIC EVALUATION REVEALED SOME DAMAGED ON THE SET'S ROTOR BLADES AND SOME RUBBING MARKS INSIDE OF THE HEAD CAVITY. THE THREADS AND DEPTH OF THE CAP AND HEAD WERE WITHIN SPECIFICATION. ALTHOUGH THE RETURNED HANDPIECE MET ALL SPECIFICATION CRITERIA, IT WAS NOTED BY MANUFACTURING PERSONNEL THAT THE HANDPIECE IS NOISY WHICH THEN CAUSED THE HANDPIECE TO FAIL AS AN OVERALL PRODUCTION TESTING RESULT.

Description of Event or Problem · 1

IN THIS EVENT IT WAS REPORTED THAT CAP UNSCREWED FROM A TRADITION HANDPIECE WHILE IN USE. THE REPORTED COMPLAINT DID NOT RESULT IN AN INJURY OR NEED FOR INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
652673	TRADITION PUSH BUTTON FIBER OPTIC HS HANDPIECE	AIR-POWERED DENTAL HANDPIECE	EFB	DENTSPLY PROFESSIONAL

Patients

Seq	Age	Sex	Outcome	Treatment
1