MAUDE Adverse Event Report: COLTENE WHALEDENT INC. PARAPOST FIBER LUX INTRO KIT; DENTAL KIT (DRILLS, POSTS)

Model Number	PF170
Medical Device Problem Codes	Fracture (1260); Material Too Rigid or Stiff (1544); Improper or Incorrect Procedure or Method (2017); Dull, Blunt (2407); Insufficient Device Problem Information (3190); Material Too Soft/Flexible (4007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) was cementing a post in tooth 21, and barely pushed down on the rheostat drill, and it broke in the patient's mouth.First time using kit.Blue drill is still in patient's mouth and they left it in as a post and cemented it in.Doctor wanted us to be aware.
Additional Manufacturer Narrative
No product was returned for this investigation.The following are possible root causes of the drill breaking: 1) the drill is dull.2) a defect is present in the material.3) insufficient heat treatment of the drill.4) incorrect pressure or speed used by the dentist during the procedure.A conclusive root cause could not be determined.

• Brand Name: PARAPOST FIBER LUX INTRO KIT
• Common Device Name: DENTAL KIT (DRILLS, POSTS)
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 9109415
• Report Number: 2416455-2019-00003
• Device Sequence Number: 3108684
• Product Code: ELR
• UDI-Device Identifier: D661PF1701
• UDI-Public: D661PF1701
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PF170
• Device Catalogue Number: PF170
• Device Lot Number: I42379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other