MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES GATES GLIDDEN DRILL STAINLESS; DRILL, DENTAL, INTRAORAL

Catalog Number 671501

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 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 a gates drill broke halfway up the shank; the separated piece was retrieved from the canal.

Manufacturer Narrative

The involved gates have been analyzed and turn out to have no damage.Involved product broken during use was not returned and cannot be analyzed.These gates have been measured and are matching to the drawing.No unused gate is available for evaluation.Nothing unusual to report was found during dhr review.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: GATES GLIDDEN DRILL STAINLESS
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• 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 ; 7178494229
• MDR Report Key: 5084238
• MDR Text Key: 26486699
• Report Number: 8031010-2015-00043
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 671501
• Device Lot Number: 1216269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1