MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY SOLO DIAMOND; DIAMOND, DENTAL BURR

Catalog Number 811037C

Device Problems Material Twisted/Bent (2981); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

The dentist pushed the foot pedal to the floor indicating that the electric handpiece holding the diamond burr would have been at about 200,000 to 250,000 rpms.Since the head of the diamond is not symmetric and has a overall head diameter of 3.7mm, the maximum operation speed as recommended per the ifu is only 120,000.An non-symmetrical and large diamond head being operated at double the maximum speed would cause the diamond to bend.Therefore, the malfunction is attributed to user error.

Event Description

The shank of the diamond bur bent while being used in a nsk electric handpiece.The shank bent while entering into the patient's mouth and prior to shaping the tooth.

• Brand Name: SOLO DIAMOND
• Type of Device: DIAMOND, DENTAL BURR
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): ABRASIVE TECHNOLOGY, LLC; 8400 green meadows drive north; lewis center OH 43035
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396069
• MDR Report Key: 17071722
• MDR Text Key: 316625494
• Report Number: 2511556-2023-00004
• Device Sequence Number: 1
• Product Code: DZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 811037C
• Device Lot Number: 08KK
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other