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 01/17/2024

Event Type  malfunction  

Event Description

On 1/17 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 they were putting the minikin channeler into the max premolar tooth when metal of channeler broke into tooth.The practitioner then stated that they left the channeler in the tooth and used a second channeler to place a pin in a second area of the same premolar.Per the customer, the drill was 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: 18722769
• MDR Text Key: 336640970
• Report Number: 2416455-2024-00002
• 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

• Date FDA Received: 02/16/2024
• 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
• Date Manufacturer Received: 01/17/2024
• 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