MAUDE Adverse Event Report: COLTENE WHALEDENT INC. MINIKIN; DENTAL DRILL

Catalog Number L511

Device Problem Fracture (1260)

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

On 12/27 the customer stated that the l511 pin driver broke in the patient's mouth.The customer stated that the patient was not hurt.The customer then provided an assessment form where they stated that the driver separated in the patient's tooth while making the pin hole.Per the customer, the drill was then left in the patient's tooth to act as the "pin" against the drills indications.Therefore, out of an abundance of caution and per 21 cfr 803, this event will be reported to the fda.

• Brand Name: MINIKIN
• Type of Device: DENTAL DRILL
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer (Section G): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer Contact: tricia cregger ; 235 ascot parkway; cuyahoga falls, OH 44223
• MDR Report Key: 18600800
• MDR Text Key: 335080163
• Report Number: 2416455-2024-00001
• Device Sequence Number: 1
• Product Code: DZA
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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: L511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1