MAUDE Adverse Event Report: ULTRADENT PRODUCTS INC. UNICORE DRILL SIZE 31 REFILL

Catalog Number 7121

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2015

Event Type  malfunction  

Manufacturer Narrative

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.After evaluation of returned drill it was determined that the drill had previously been damaged by being grasped tightly on the cutting edge by a device which may have been used to insert the drill into the hand piece.Refile due to issues with uploading to maude data base.

Event Description

Dentist had a #1 unicore drill break in the canal he was able to retrieve the broken portion of the drill from the tooth and proceed with procedure.Dentist reported all is fine with the tooth.

• Brand Name: UNICORE DRILL SIZE 31 REFILL
• Type of Device: UNICORE DRILL
• Manufacturer (Section D): ULTRADENT PRODUCTS INC.; 505 west 10200 south; south jordan UT 84095
• Manufacturer (Section G): ULTRADENT PRODUCTS; 505 west 10200 south; south jordan UT 84095
• Manufacturer Contact: rona murphy ; 505 west 10200 south; south jordan, UT 84095 ; 8005525512
• MDR Report Key: 7139675
• MDR Text Key: 95852639
• Report Number: 1718912-2017-00040
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 7121
• Device Lot Number: B8NYL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 91