MAUDE Adverse Event Report: GATES AD 32MM; DRILL, DENTAL, INTRAORAL

Catalog Number 671501

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a gates drill broke during use.No injury resulted and all the broken parts have been retrieved from the patient's mouth.

Manufacturer Narrative

Involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1587046).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: GATES AD 32MM
• Type of Device: DRILL, DENTAL, INTRAORAL
• MDR Report Key: 11189485
• MDR Text Key: 228486218
• Report Number: 8031010-2020-00287
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• PMA/PMN Number: NA#S-P#NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 671501
• Device Lot Number: 1587046
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1