MAUDE Adverse Event Report: DENTSPLY MAILLEFER GATES GLIDDEN DRILL; DRILL, DENTAL, INTRAORAL

Catalog Number 671531

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

However, 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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that gates drills separated.No patient injury or medical intervention was reported.

Manufacturer Narrative

The gates returned in loose have been observed and has no damage.Involved gate glidden drills which have broken during use have not been returned and cannot be analyzed.Nothing unusual to report was found during dhr review.Unused product has been evaluated, the gates were found in compliance with specifications after torque test.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: GATES GLIDDEN DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178457551
• MDR Report Key: 6541941
• MDR Text Key: 74495144
• Report Number: 8031010-2017-00028
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 671531
• Device Lot Number: 1300997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1